Roflumilast Clinical Trials

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: June 12, 2026.

119

Total Trials

Recruiting

Completed

173,352

Total Enrollment

States

Roflumilast Evidence & Publications

117 peer-reviewed publications + per-arm primary-outcome data from 19 pivotal trials.

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Roflumilast Clinical Trials

Sortable list of all 119 Roflumilast trials — recruiting status, pivotal acronyms, indication grouping, NCT links.

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What Is Roflumilast?

Roflumilast is an FDA-approved medication for chronic obstructive pulmonary disease (COPD) and plaque psoriasis. It is a phosphodiesterase-4 (PDE-4) inhibitor. PDE-4 is an enzyme found in inflammatory cells that breaks down cyclic adenosine monophosphate (cAMP). By inhibiting PDE-4, Roflumilast increases intracellular cAMP levels, which helps to reduce inflammation in the body. This mechanism of action makes it useful for conditions characterized by inflammation, particularly in the lungs and skin.

Roflumilast has been studied in 119 clinical trials involving a total of 173,352 participants. The first trial began on 2003-06-10, and the latest is projected to conclude on 2026-05-05. Currently, 11 trials are recruiting participants, while 79 trials are completed.

Uses and Conditions Under Study

Roflumilast is primarily approved for and studied in conditions involving inflammation, particularly affecting the respiratory system and skin.

Respiratory Conditions: Roflumilast is FDA-approved for chronic obstructive pulmonary disease (COPD). It has been investigated in 14 trials for COPD, 7 trials for Chronic Obstructive Pulmonary Disease (COPD), and 14 trials for Chronic Obstructive Pulmonary Disease. It is also being studied for other lung conditions such as Asthma (7 trials), Non-cystic Fibrosis Bronchiectasis (2 trials), chronic bronchitis, and Acute Respiratory Distress Syndrome (ARDS). Its anti-inflammatory action may help reduce symptoms and improve lung function in these conditions.
Skin Conditions: Roflumilast is FDA-approved in its topical form for plaque psoriasis. It has been studied in 6 trials for Plaque Psoriasis and 3 trials for Psoriasis. Its role as a PDE-4 inhibitor helps to reduce the inflammation and cell overgrowth characteristic of psoriasis. It is also being investigated for Atopic Dermatitis (5 trials) and Atopic Dermatitis Eczema (3 trials), where its anti-inflammatory effects may alleviate skin irritation and itching.
Other Conditions: Roflumilast is also under investigation for other conditions, including Obesity (5 trials).

Dosing

Roflumilast is available in various forms and strengths, depending on the condition being treated or studied.

Oral Forms: The FDA-approved oral dose for COPD is 500 micrograms (mcg) once daily. Other oral doses studied in trials include 50 mcg, 100 mcg, 250 mcg, 300 mcg, 375 mcg, and 1000 mcg. Some studies have explored alternative dosing schedules, such as 500 mcg every other day, or combinations with other medications like montelukast, metformin, or pioglitazone.
Topical Forms: For skin conditions, Roflumilast is available as a foam and a cream. The 0.3% topical foam has been studied for conditions like plaque psoriasis and atopic dermatitis, typically applied once daily to affected areas. Various cream strengths have also been investigated, including 0.05%, 0.15%, 0.3%, and 0.5% Roflumilast cream.
Investigational Devices: A microdevice, about the size of a grain of rice, containing Roflumilast, is being tested to assess skin reactions to treatments for atopic dermatitis and psoriasis.

The specific dosage, form, and frequency of Roflumilast depend on the condition, patient response, and whether it is an approved treatment or part of a clinical investigation.

Side Effects

In clinical trials, patients taking Roflumilast experienced certain side effects more often than those taking a placebo. The most commonly reported side effects included:

Insomnia (difficulty sleeping): 16.9% of patients taking Roflumilast experienced insomnia, compared to 3.2% on placebo. This data came from studies involving 201 patients on Roflumilast.
Dizziness: 12.2% of patients on Roflumilast reported dizziness, while 7.1% on placebo did. This was observed in studies with 271 patients taking Roflumilast.
Diarrhea: 10.0% of patients taking Roflumilast experienced diarrhea, compared to 3.4% on placebo. This finding is based on a large dataset of 5153 patients on Roflumilast across 14 trials.
Weight decreased: 8.6% of patients on Roflumilast reported weight loss, versus 2.3% on placebo. This was seen in studies with 4612 patients taking Roflumilast.
Headache: 7.4% of patients taking Roflumilast had headaches, compared to 4.8% on placebo.
Decreased appetite: 6.5% of patients on Roflumilast experienced a decrease in appetite, compared to 1.5% on placebo.
Nausea: 6.1% of patients taking Roflumilast reported nausea, while 2.0% on placebo did.

Other events like chronic obstructive pulmonary disease, nasopharyngitis, upper respiratory tract infection, bronchitis, and back pain were reported at similar or lower rates in patients taking Roflumilast compared to placebo.

Clinical Trial Results

Clinical trials have evaluated the effectiveness of Roflumilast in patients with chronic obstructive pulmonary disease (COPD).

Reduced COPD Exacerbations

In several studies, Roflumilast helped reduce the rate of moderate or severe COPD exacerbations (flare-ups):

In the AURA study (NCT00297102), patients taking Roflumilast experienced an average of 1.077 exacerbations per year, compared to 1.266 exacerbations per year for those on placebo.
The HERMES study (NCT00297115) showed 1.210 exacerbations per year with Roflumilast versus 1.485 exacerbations per year with placebo.
In the EOS study (NCT00313209), the rate was 1.9 exacerbations per year for Roflumilast compared to 2.4 exacerbations per year for placebo.
The HELIOS study (NCT00424268) reported 0.262 exacerbations per year with Roflumilast versus 0.342 exacerbations per year with placebo.

One study conducted in China, Hong Kong, and Singapore (NCT01313494) reported a mean rate of 0.55 exacerbations per year for Roflumilast compared to 0.44 exacerbations per year for placebo, and a shorter time to the first exacerbation (67.0 days for Roflumilast vs. 86.0 days for placebo).

Improved Lung Function

Roflumilast consistently demonstrated improvements in lung function, measured by Forced Expiratory Volume in 1 second (FEV1), which indicates how much air a person can exhale in one second. Higher FEV1 values suggest better lung function:

In the AURA study (NCT00297102), Roflumilast led to an improvement of 57 mL in post-bronchodilator FEV1, compared to 8 mL with placebo. Pre-bronchodilator FEV1 also improved by 46 mL with Roflumilast versus 8 mL with placebo.
The HERMES study (NCT00297115) showed Roflumilast improved post-bronchodilator FEV1 by 44 mL, while placebo saw a decrease of 17 mL. Pre-bronchodilator FEV1 improved by 33 mL with Roflumilast, compared to a 25 mL decrease with placebo.
The EOS study (NCT00313209) reported a 68 mL improvement in post-bronchodilator FEV1 with Roflumilast, versus 8 mL with placebo.
The HELIOS study (NCT00424268) showed a 74 mL improvement in post-bronchodilator FEV1 with Roflumilast, while placebo saw a 7 mL decrease.
The study in China, Hong Kong, and Singapore (NCT01313494) also found that Roflumilast led to an increase of 0.045 liters in post-bronchodilator FEV1 and 0.049 liters in pre-bronchodilator FEV1 from baseline, while placebo groups experienced slight decreases.

Improved Breathing and Symptoms

Roflumilast also showed benefits in improving patients' breathing and overall symptoms:

The Transition Dyspnea Index (TDI) focal score, which measures shortness of breath, generally improved more with Roflumilast. For example, in the AURA study (NCT00297102), Roflumilast patients had a score of 0.658 compared to 0.426 for placebo (higher scores indicate better breathing). Similar improvements were seen in HERMES (NCT00297115) and HELIOS (NCT00424268).
In the HELIOS study (NCT00424268), the Shortness of Breath Questionnaire (SOBQ) total score improved more with Roflumilast (-3.4) compared to placebo (-0.7), where lower scores indicate less shortness of breath.

Currently Recruiting Trials

Roflumilast is currently being investigated in a variety of clinical trials, exploring its potential to treat a range of conditions. These studies aim to understand how safe and effective roflumilast is, sometimes alone and sometimes in combination with other treatments. For patients with rheumatoid arthritis, a Phase 2 study sponsored by Horus University, NCT07566351, is recruiting 90 participants to evaluate roflumilast and desloratadine as an add-on therapy. This trial seeks to help individuals who still experience active disease despite standard treatments. Several studies are also focusing on skin conditions. Beth Israel Deaconess Medical Center is sponsoring a Phase 2 study, NCT07263230, enrolling 20 patients to assess the safety and efficacy of roflumilast 0.3% topical foam for Hidradenitis Suppurativa (HS). Tulane University is also studying the 0.3% foam in HS patients in a Phase 2a open-label study, NCT07077902, with an enrollment target of 10 individuals. In other dermatological investigations, a pilot study, NCT07297602, is evaluating oral roflumilast for moderate to severe atopic dermatitis in 36 patients aged 12 and older. Similarly, Ahmed Ibrahim is sponsoring a Phase 2 pilot study, NCT07233291, for 36 adults with moderate to severe psoriasis, assessing oral roflumilast. For non-segmental vitiligo, Derm Texas, PLLC is conducting a Phase 2 proof-of-concept study, NCT07105254, in 20 pediatric patients using roflumilast foam 0.3%. Beyond skin conditions, roflumilast is being explored in other areas. The University of Texas Health Science Center at San Antonio is running a Phase 1 study, NCT06977711, for 10 participants with high-risk diffuse large B-cell lymphoma, combining roflumilast with other therapies. A Phase 3 study, NCT06860958, sponsored by Tanta University, is enrolling 60 patients to investigate roflumilast as an adjunct to antidepressants for major depressive disorder. For plaque psoriasis, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is sponsoring a Phase 3 study, NCT06648772, with 189 subjects to evaluate roflumilast cream 0.3%. Lastly, Rao Dermatology is conducting a Phase 4 study, NCT06440473, with 3 healthy volunteers to visualize the deposition of topical roflumilast 0.3% (Zoryve) in healthy skin.

Where to Participate

Clinical trials for roflumilast are currently recruiting participants across various locations in the United States. In total, there are 10 sites located in 7 cities across 5 states. The locations with the most recruiting studies include:

New Orleans, Louisiana (3 sites)
San Antonio, Texas (2 sites)

Other cities with active recruiting sites are Tucson, Arizona; Atlantic Highlands, New Jersey; Dallas, Texas; Boston, Massachusetts; and Covington, Louisiana. Eligibility for these studies is broad, welcoming participants aged from 2 to 90 years. Both male and female individuals are eligible to join. Some studies also include healthy volunteers, and children are able to participate in specific trials.

Development Timeline

The journey of roflumilast in clinical development began on June 10, 2003, marking the start of its extensive research. Since then, a total of 119 trials have been conducted or are ongoing, involving over 173,352 participants. Early development explored conditions like IBS-C and hyperphosphatemia. Over time, the focus expanded significantly, driven by various sponsors, with AstraZeneca leading a substantial number of studies (36 trials) and Arcutis Biotherapeutics, Inc. also contributing significantly (12 trials). The pipeline diversified to include a wide array of conditions, particularly in respiratory and dermatological health. Roflumilast has been investigated for asthma, chronic obstructive pulmonary disease (COPD), plaque psoriasis, atopic dermatitis, and hidradenitis suppurativa. The drug's development has progressed through all phases of clinical research, with a strong presence in later stages. There have been 38 Phase 2 trials, 36 Phase 3 trials, and 19 Phase 4 trials, indicating a mature and continuously expanding research program. Beyond its initial indications, roflumilast's potential has been explored in areas such as diffuse large B-cell lymphoma, major depressive disorder, and even non-segmental vitiligo. The latest trial for roflumilast is projected to conclude on May 5, 2026, highlighting ongoing commitment to understanding its full therapeutic potential.

Roflumilast Development Timeline

Clinical trial activity from 2003 to 2026.

2026

NCT07352566PHASE4not yet recruiting

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

10 enrolled

NCT07560618PHASE4not yet recruiting

Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.

40 enrolled

NCT07566351PHASE2recruiting

Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis

90 enrolled

NCT07543640PHASE2not yet recruiting

EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.

56 enrolled

NCT07263230PHASE2recruiting

The Safety and Efficacy of Roflumilast Foam in HS

20 enrolled

NCT07314242PHASE2not yet recruiting

A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

120 enrolled

2025

NCT07297602PHASE2recruiting

Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study

36 enrolled

NCT07077902PHASE2recruiting

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa

10 enrolled

NCT07233291PHASE2recruiting

A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults

36 enrolled

NCT07105254PHASE2recruiting

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)

20 enrolled

NCT06977711PHASE1recruiting

Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

10 enrolled

NCT06860958PHASE3recruiting

Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

60 enrolled

NCT07174011PHASE4completed

Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata

50 enrolled

2024

NCT06631170PHASE3completed

Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

354 enrolled

NCT06648772PHASE3recruiting

Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

189 enrolled

NCT06457191PHASE1active not recruiting

Roflumilast and TMS Motor Plasticity

20 enrolled

NCT06440473PHASE4unknown

Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

3 enrolled

NCT05796271PHASE1withdrawn

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

0 enrolled

2023

NCT05682859PHASE4unknown

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

40 enrolled

NCT05884281PHASE1/PHASE2unknown

Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

60 enrolled

NCT05763082PHASE3completed

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

414 enrolled

NCT05684484PHASE4completed

Role of Roflumilast in Ulcerative Colitis

52 enrolled

NCT05684744PHASE2/PHASE3completed

Roflumilast Versus Methotrexate in Psoriasis

30 enrolled

2022

NCT05418049PHASE2active not recruiting

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

45 enrolled

NCT05369793PHASE3completed

Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy

60 enrolled

NCT05278624PHASE2completed

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

40 enrolled

NCT06677788PHASE2completed

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

55 enrolled

NCT04369547PHASE1withdrawn

Roflumilast TMS-EEG Plasticity

0 enrolled

2021

NCT04658654PHASE2unknown

Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients

81 enrolled

NCT05028582PHASE3completed

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

432 enrolled

NCT04636814PHASE3terminated

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

3,973 enrolled

NCT04973228PHASE3completed

Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

457 enrolled

NCT04854811PHASE2completed

Roflumilast to Treat Cognitive Sequela After Stroke

100 enrolled

NCT04800172PHASE3completed

The Possible Effects of Roflumilast on Obesity Related Disorders

66 enrolled

NCT04845620PHASE3completed

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

652 enrolled

NCT04744090PHASE2completed

Roflumilast as add-on Therapy in Early Cases of ARDS

76 enrolled

NCT04755946PHASE3unknown

Possible Role of Roflumilast in Diabetic Nephropathy

48 enrolled

NCT04773600PHASE3completed

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

683 enrolled

NCT04751071PHASE1/PHASE2withdrawn

The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

0 enrolled

NCT04773587PHASE3completed

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

654 enrolled

NCT04549870PHASE2completed

Efficacy of Roflumilast in the Treatment of Psoriasis

46 enrolled

2020

NCT04322929PHASE2completed

Roflumilast in Non-CF Bronchiectasis Study (2019)

42 enrolled

NCT04286607PHASE3completed

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

333 enrolled

NCT04069312PHASE4completed

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

1,032 enrolled

NCT04128007PHASE2completed

Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

304 enrolled

2019

NCT04211363PHASE3completed

Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

439 enrolled

NCT03988816PHASE2unknown

Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis

30 enrolled

NCT04091646PHASE2completed

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

226 enrolled

NCT04090294EARLY_PHASE1unknown

Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

35 enrolled

NCT03916081PHASE2completed

Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

136 enrolled

NCT04108377PHASE1terminated

Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

5 enrolled

2018

NCT03764475PHASE2completed

Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

332 enrolled

NCT03638258PHASE2completed

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

331 enrolled

NCT03532490PHASE2completed

Trial of Roflumilast in Asthma Management (TRIM)

38 enrolled

NCT03458546PHASE1completed

Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma

14 enrolled

NCT03428334PHASE2completed

Roflumilast in Non-CF Bronchiectasis Study

20 enrolled

NCT02743377PHASE1/PHASE2completed

PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome

16 enrolled

NCT06643221EARLY_PHASE1recruiting

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

200 enrolled

2016

NCT02835716unknown

Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO

150 enrolled

NCT02671942PHASE2terminated

A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients

55 enrolled

2015

NCT02451540PHASE2terminated

Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

13 enrolled

NCT04122547PHASE3completed

Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

40 enrolled

2014

NCT02340520PHASE3completed

Enhancement of Corticosteroid Efficacy in COPD

13 enrolled

NCT02165826PHASE3completed

Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD

1,323 enrolled

NCT02187250PHASE4completed

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

45 enrolled

NCT02079844PHASE1completed

Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia

20 enrolled

NCT02051335PHASE1completed

Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults

27 enrolled

2013

NCT02018432PHASE4unknown

Strategy to Improve Adherence of Roflumilast

80 enrolled

NCT03381573completed

Long-term Observational Study of the Safety of Roflumilast

135,856 enrolled

NCT01973998PHASE3completed

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

68 enrolled

NCT02037672PHASE4completed

PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

36 enrolled

NCT01888952EARLY_PHASE1completed

Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)

10 enrolled

NCT01703260PHASE2terminated

Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

20 enrolled

NCT01856764PHASE2completed

Topical Roflumilast in Adults With Atopic Dermatitis

40 enrolled

NCT01862029PHASE1/PHASE2completed

Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals

24 enrolled

NCT01830959PHASE4unknown

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

50 enrolled

NCT03073798PHASE4completed

The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis

12 enrolled

NCT01701934PHASE2terminated

Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease

14 enrolled

NCT02097992PHASE1/PHASE2completed

Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

11 enrolled

NCT01765192PHASE2completed

Roflumilast Plus Montelukast in Adults With Severe Asthma

64 enrolled

NCT01745848PHASE4completed

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

26 enrolled

2012

NCT01730404PHASE2completed

Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

55 enrolled

NCT02068456completed

Post Marketing Surveillance of Roflumilast in Korea

1,837 enrolled

NCT01664624PHASE1completed

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

40 enrolled

NCT01849341PHASE4completed

Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily

105 enrolled

NCT01572948NAcompleted

A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

27 enrolled

NCT01630200PHASE4completed

Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)

80 enrolled

NCT01595750PHASE4unknown

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease

150 enrolled

NCT01580748PHASE2unknown

Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

25 enrolled

NCT01473758PHASE2terminated

Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

81 enrolled

NCT01509677PHASE3completed

Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease

158 enrolled

2011

NCT01480661PHASE4completed

Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

41 enrolled

NCT01433666PHASE2completed

Roflumilast and Cognition

22 enrolled

NCT01443845PHASE4completed

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

2,354 enrolled

NCT01354782PHASE1completed

Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

32 enrolled

NCT01329029PHASE4completed

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

1,945 enrolled

NCT01313494PHASE3completed

A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

626 enrolled

2008

NCT00746434PHASE2withdrawn

A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis

0 enrolled

NCT00746382PHASE2withdrawn

A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)

0 enrolled

2007

NCT00424268PHASE3completed

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

743 enrolled

2006

NCT01140542PHASE2completed

Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study

487 enrolled

NCT00313209PHASE3completed

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

933 enrolled

NCT00297115PHASE3completed

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

1,568 enrolled

NCT00297102PHASE3completed

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

1,523 enrolled

2005

NCT00242320PHASE3completed

Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

551 enrolled

NCT00246935PHASE3completed

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

150 enrolled

2004

NCT01365533PHASE2completed

A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma

48 enrolled

NCT00246922PHASE3completed

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).

150 enrolled

NCT00242294PHASE2/PHASE3completed

Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

570 enrolled

NCT00108823PHASE3completed

The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

550 enrolled

NCT00163475PHASE3completed

Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

511 enrolled

NCT00242307PHASE2/PHASE3completed

Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

450 enrolled

NCT00940329PHASE1completed

Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol

27 enrolled

2003

NCT00076076PHASE3completed

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

822 enrolled

NCT00076089PHASE3completed

OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

1,100 enrolled

NCT00073177PHASE3completed

Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

819 enrolled

NCT00062582PHASE3completed

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

1,000 enrolled

NCT00163527PHASE3completed

Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

2,054 enrolled

NCT00430729PHASE3completed

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

1,100 enrolled

Conditions Under Study

Condition	NCT ID	Title	Status	Phase	Enrollment
COPD	NCT02340520	Enhancement of Corticosteroid Efficacy in COPD	completed	PHASE3	13
	NCT03381573	Long-term Observational Study of the Safety of Roflumilast	completed	N/A	135,856
	NCT01973998	Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization	completed	PHASE3	68
	NCT03073798	The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis	completed	PHASE4	12
	NCT02097992	Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD	completed	PHASE1/PHASE2	11
	NCT01730404	Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients	completed	PHASE2	55
	NCT01572948	A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)	completed	NA	27
	NCT01509677	Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease	completed	PHASE3	158
	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
	NCT01313494	A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:	completed	PHASE3	626
	NCT00242320	Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)	completed	PHASE3	551
	NCT00076089	OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)	completed	PHASE3	1,100
	NCT00062582	Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)	completed	PHASE3	1,000
	NCT00430729	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)	completed	PHASE3	1,100
Chronic Obstructive Pulmonary Disease	NCT04636814	A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)	terminated	PHASE3	3,973
	NCT02671942	A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients	terminated	PHASE2	55
	NCT02018432	Strategy to Improve Adherence of Roflumilast	unknown	PHASE4	80
	NCT01701934	Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease	terminated	PHASE2	14
	NCT01745848	Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD	completed	PHASE4	26
	NCT02068456	Post Marketing Surveillance of Roflumilast in Korea	completed	N/A	1,837
	NCT01595750	Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease	unknown	PHASE4	150
	NCT01509677	Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease	completed	PHASE3	158
	NCT01354782	Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects	completed	PHASE1	32
	NCT01329029	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)	completed	PHASE4	1,945
	NCT00424268	Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)	completed	PHASE3	743
	NCT00076089	OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)	completed	PHASE3	1,100
	NCT00062582	Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)	completed	PHASE3	1,000
	NCT00430729	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)	completed	PHASE3	1,100
Asthma	NCT04108377	Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma	terminated	PHASE1	5
	NCT03532490	Trial of Roflumilast in Asthma Management (TRIM)	completed	PHASE2	38
	NCT01765192	Roflumilast Plus Montelukast in Adults With Severe Asthma	completed	PHASE2	64
	NCT00163475	Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)	completed	PHASE3	511
	NCT00076076	The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)	completed	PHASE3	822
	NCT00073177	Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)	completed	PHASE3	819
	NCT00163527	Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)	completed	PHASE3	2,054
Chronic Obstructive Pulmonary Disease (COPD)	NCT02165826	Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD	completed	PHASE3	1,323
	NCT01849341	Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily	completed	PHASE4	105
	NCT00313209	Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)	completed	PHASE3	933
	NCT00297115	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)	completed	PHASE3	1,568
	NCT00297102	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)	completed	PHASE3	1,523
	NCT00246935	Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)	completed	PHASE3	150
	NCT00242294	Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)	completed	PHASE2/PHASE3	570
Plaque Psoriasis	NCT06648772	Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study	recruiting	PHASE3	189
	NCT05763082	Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis	completed	PHASE3	414
	NCT04128007	Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis	completed	PHASE2	304
	NCT03764475	Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis	completed	PHASE2	332
	NCT03638258	The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis	completed	PHASE2	331
	NCT00746434	A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis	withdrawn	PHASE2	0
Obesity	NCT04800172	The Possible Effects of Roflumilast on Obesity Related Disorders	completed	PHASE3	66
	NCT03532490	Trial of Roflumilast in Asthma Management (TRIM)	completed	PHASE2	38
	NCT02187250	PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome	completed	PHASE4	45
	NCT02037672	PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome	completed	PHASE4	36
	NCT01862029	Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals	completed	PHASE1/PHASE2	24
Atopic Dermatitis	NCT07560618	Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.	not yet recruiting	PHASE4	40
	NCT07352566	Utilization of a Microdevice for Psoriasis and Atopic Dermatitis	not yet recruiting	PHASE4	10
	NCT07297602	Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study	recruiting	PHASE2	36
	NCT03916081	Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis	completed	PHASE2	136
	NCT01856764	Topical Roflumilast in Adults With Atopic Dermatitis	completed	PHASE2	40
Psoriasis	NCT07352566	Utilization of a Microdevice for Psoriasis and Atopic Dermatitis	not yet recruiting	PHASE4	10
	NCT05684744	Roflumilast Versus Methotrexate in Psoriasis	completed	PHASE2/PHASE3	30
	NCT04549870	Efficacy of Roflumilast in the Treatment of Psoriasis	completed	PHASE2	46
Atopic Dermatitis Eczema	NCT04845620	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)	completed	PHASE3	652
	NCT04773600	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)	completed	PHASE3	683
	NCT04773587	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis	completed	PHASE3	654
Non-cystic Fibrosis Bronchiectasis	NCT04322929	Roflumilast in Non-CF Bronchiectasis Study (2019)	completed	PHASE2	42
	NCT03428334	Roflumilast in Non-CF Bronchiectasis Study	completed	PHASE2	20
Chronic Plaque Psoriasis	NCT04286607	Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis	completed	PHASE3	333
	NCT04211363	Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis	completed	PHASE3	439
Pulmonary Disease, Chronic Obstructive	NCT02451540	Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging	terminated	PHASE2	13
	NCT01480661	Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients	completed	PHASE4	41
Bronchiectasis	NCT04090294	Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis	unknown	EARLY_PHASE1	35
	NCT04122547	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis	completed	PHASE3	40
Bronchial Asthma	NCT00246922	Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).	completed	PHASE3	150
	NCT00242307	Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).	completed	PHASE2/PHASE3	450
Seborrheic Dermatitis	NCT04973228	Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)	completed	PHASE3	457
	NCT04091646	Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis	completed	PHASE2	226
Lymphoma, B-Cell	NCT05796271	Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy	withdrawn	PHASE1	0
	NCT03458546	Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma	completed	PHASE1	14
PCOS	NCT02187250	PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome	completed	PHASE4	45
	NCT02037672	PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome	completed	PHASE4	36
Chronic Bronchitis	NCT04069312	Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)	completed	PHASE4	1,032
	NCT03073798	The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis	completed	PHASE4	12
Chronic Obstructive Pulmonary Disease, COPD	NCT00108823	The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)	completed	PHASE3	550
COPD (Chronic Obstructive Pulmonary Disease)	NCT07314242	A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD	not yet recruiting	PHASE2	120
COPD Exacerbation	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Dementia	NCT01433666	Roflumilast and Cognition	completed	PHASE2	22
Depressive Disorder, Major	NCT06860958	Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients	recruiting	PHASE3	60
Dermatitis	NCT00746382	A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)	withdrawn	PHASE2	0
Diabetes Mellitus Type 2	NCT01140542	Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study	completed	PHASE2	487
Diabetic Nephropathies	NCT04755946	Possible Role of Roflumilast in Diabetic Nephropathy	unknown	PHASE3	48
Diabetic Neuropathies	NCT05369793	Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy	completed	PHASE3	60
Diffuse Large B-cell Lymphoma	NCT06977711	Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)	recruiting	PHASE1	10
Donor Lymphocyte Infusion	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Drug Intervention	NCT04854811	Roflumilast to Treat Cognitive Sequela After Stroke	completed	PHASE2	100
Emphysema	NCT03073798	The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis	completed	PHASE4	12
Exacerbation Copd	NCT04122547	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis	completed	PHASE3	40
Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis	NCT07543640	EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.	not yet recruiting	PHASE2	56
Fragile X Syndrome	NCT05418049	Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge	active not recruiting	PHASE2	45
Functional Recovery	NCT04854811	Roflumilast to Treat Cognitive Sequela After Stroke	completed	PHASE2	100
Healthy	NCT00940329	Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol	completed	PHASE1	27
Healthy Skin	NCT06440473	Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin	unknown	PHASE4	3
Hematopoetic Stem Cell Transplantation	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Hidradenitis Suppurativa	NCT07077902	A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa	recruiting	PHASE2	10
Hidradenitis Suppurativa (HS)	NCT07263230	The Safety and Efficacy of Roflumilast Foam in HS	recruiting	PHASE2	20
ITCH	NCT07560618	Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.	not yet recruiting	PHASE4	40
Leukemia	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Lung Diseases	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Lung Function Decreased	NCT04122547	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis	completed	PHASE3	40
Lymphoma	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Major Depressive Disorder	NCT04751071	The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients	withdrawn	PHASE1/PHASE2	0
Memory	NCT04854811	Roflumilast to Treat Cognitive Sequela After Stroke	completed	PHASE2	100
Memory Impairment	NCT02051335	Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults	completed	PHASE1	27
Metabolic Syndrome	NCT01701934	Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease	terminated	PHASE2	14
Mild Cognitive Impairment	NCT04658654	Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients	unknown	PHASE2	81
Mild Dementia	NCT04658654	Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients	unknown	PHASE2	81
Nervous System Disease	NCT02743377	PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome	completed	PHASE1/PHASE2	16
Non-Alcoholic Steatohepatitis (NASH)	NCT06677788	Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH	completed	PHASE2	55
Non-segmental Vitiligo	NCT07105254	An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)	recruiting	PHASE2	20
Nonalcoholic Steatohapatitis	NCT01703260	Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis	terminated	PHASE2	20
Other Conditions of Brain	NCT06457191	Roflumilast and TMS Motor Plasticity	active not recruiting	PHASE1	20
Peripheral Neuropathy	NCT05884281	Efficacy of Roflumilast in Prevention of Peripheral Neuropathy	unknown	PHASE1/PHASE2	60
PreDiabetes	NCT04800172	The Possible Effects of Roflumilast on Obesity Related Disorders	completed	PHASE3	66
Psoriasis (PsO)	NCT07233291	A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults	recruiting	PHASE2	36
Pulmonary Disease	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Respiratory Disorders	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Respiratory Distress Syndrome, Adult	NCT04744090	Roflumilast as add-on Therapy in Early Cases of ARDS	completed	PHASE2	76
Rheumatoid Arthritis	NCT07566351	Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis	recruiting	PHASE2	90
Rosacea	NCT05278624	Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea	completed	PHASE2	40
Sarcoidosis	NCT01830959	Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)	unknown	PHASE4	50
Scalp Psoriasis	NCT05028582	Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)	completed	PHASE3	432
Schizophrenia	NCT02079844	Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia	completed	PHASE1	20
Symptomatic Bronchiectasis	NCT01580748	Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients	unknown	PHASE2	25
Synaptic Plasticity	NCT04369547	Roflumilast TMS-EEG Plasticity	withdrawn	PHASE1	0
Type 2 Diabetes	NCT01664624	Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes	completed	PHASE1	40
Type 2 Diabetes (Adult Onset)	NCT05369793	Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy	completed	PHASE3	60
Advanced B-cell Lymphoid Malignancies	NCT01888952	Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)	completed	EARLY_PHASE1	10
Ulcerative Colitis	NCT05684484	Role of Roflumilast in Ulcerative Colitis	completed	PHASE4	52
Allergic Asthma	NCT01365533	A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma	completed	PHASE2	48
Alopecia	NCT07174011	Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata	completed	PHASE4	50
Alopecia Areata	NCT07174011	Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata	completed	PHASE4	50
Alzheimer's Disease	NCT02051335	Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults	completed	PHASE1	27
Alzheimer Disease	NCT02835716	Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO	unknown	N/A	150
Amnestic Mild Cognitive Disorder	NCT04658654	Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients	unknown	PHASE2	81
Atopic Dermatitis (AD)	NCT06631170	Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis	completed	PHASE3	354
Bronchiectasis Adult	NCT03988816	Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis	unknown	PHASE2	30
CAR T-Cell Therapy	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Cell Therapy	NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200
Cerebrovascular Disorders	NCT04854811	Roflumilast to Treat Cognitive Sequela After Stroke	completed	PHASE2	100
Chronic Hand Eczema	NCT05682859	Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)	unknown	PHASE4	40
Chronic Obstructive Airway Disease	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Chronic Obstructive Lung Diseases	NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354
Chronic Obstructive Pulmonary Disease and Allied Conditions	NCT01630200	Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)	completed	PHASE4	80
Chronic Obstructive Pulmonary Disease Severe	NCT04069312	Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)	completed	PHASE4	1,032
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation	NCT01473758	Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease	terminated	PHASE2	81

All Roflumilast Clinical Trials (119)

NCT ID	Title	Status	Phase	Enrollment	Sponsor
NCT07560618	Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.	not yet recruiting	PHASE4	40	Integrative Skin Science and Research
NCT07566351	Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis	recruiting	PHASE2	90	Horus University
NCT07543640	EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.	not yet recruiting	PHASE2	56	Eman Raafat Said
NCT07263230	The Safety and Efficacy of Roflumilast Foam in HS	recruiting	PHASE2	20	Beth Israel Deaconess Medical Center
NCT07352566	Utilization of a Microdevice for Psoriasis and Atopic Dermatitis	not yet recruiting	PHASE4	10	University of California, San Francisco
NCT07314242	A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD	not yet recruiting	PHASE2	120	Ganzhou Hemay Pharmaceutical Co., Ltd
NCT07297602	Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study	recruiting	PHASE2	36	Nora Mohamed Abdelrazik
NCT07077902	A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa	recruiting	PHASE2	10	Tulane University
NCT07233291	A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults	recruiting	PHASE2	36	Ahmed Ibrahim
NCT07105254	An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)	recruiting	PHASE2	20	Derm Texas, PLLC
NCT06977711	Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)	recruiting	PHASE1	10	The University of Texas Health Science Center at San Antonio
NCT06860958	Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients	recruiting	PHASE3	60	Tanta University
NCT07174011	Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata	completed	PHASE4	50	Cairo University
NCT06631170	Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis	completed	PHASE3	354	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
NCT06648772	Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study	recruiting	PHASE3	189	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
NCT06457191	Roflumilast and TMS Motor Plasticity	active not recruiting	PHASE1	20	University of Calgary
NCT06440473	Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin	unknown	PHASE4	3	Rao Dermatology
NCT05796271	Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy	withdrawn	PHASE1	0	The University of Texas Health Science Center at San Antonio
NCT05682859	Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)	unknown	PHASE4	40	Jacob Pontoppidan Thyssen
NCT05884281	Efficacy of Roflumilast in Prevention of Peripheral Neuropathy	unknown	PHASE1/PHASE2	60	Mansoura University
NCT05763082	Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis	completed	PHASE3	414	Padagis LLC
NCT05684484	Role of Roflumilast in Ulcerative Colitis	completed	PHASE4	52	Tanta University
NCT05684744	Roflumilast Versus Methotrexate in Psoriasis	completed	PHASE2/PHASE3	30	Cairo University
NCT05418049	Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge	active not recruiting	PHASE2	45	Children's Hospital Medical Center, Cincinnati
NCT05369793	Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy	completed	PHASE3	60	Tanta University
NCT05278624	Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea	completed	PHASE2	40	Dermatology Consulting Services, PLLC
NCT06677788	Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH	completed	PHASE2	55	Tanta University
NCT04369547	Roflumilast TMS-EEG Plasticity	withdrawn	PHASE1	0	University of Calgary
NCT04658654	Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients	unknown	PHASE2	81	Maastricht University Medical Center
NCT05028582	Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)	completed	PHASE3	432	Arcutis Biotherapeutics, Inc.
NCT04636814	A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)	terminated	PHASE3	3,973	Chiesi Farmaceutici S.p.A.
NCT04973228	Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)	completed	PHASE3	457	Arcutis Biotherapeutics, Inc.
NCT04854811	Roflumilast to Treat Cognitive Sequela After Stroke	completed	PHASE2	100	Maastricht University
NCT04800172	The Possible Effects of Roflumilast on Obesity Related Disorders	completed	PHASE3	66	Tanta University
NCT04845620	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)	completed	PHASE3	652	Arcutis Biotherapeutics, Inc.
NCT04744090	Roflumilast as add-on Therapy in Early Cases of ARDS	completed	PHASE2	76	Cairo University
NCT04755946	Possible Role of Roflumilast in Diabetic Nephropathy	unknown	PHASE3	48	Tanta University
NCT04773600	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)	completed	PHASE3	683	Arcutis Biotherapeutics, Inc.
NCT04751071	The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients	withdrawn	PHASE1/PHASE2	0	Sadat City University
NCT04773587	Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis	completed	PHASE3	654	Arcutis Biotherapeutics, Inc.
NCT04549870	Efficacy of Roflumilast in the Treatment of Psoriasis	completed	PHASE2	46	Bispebjerg Hospital
NCT04322929	Roflumilast in Non-CF Bronchiectasis Study (2019)	completed	PHASE2	42	The University of Hong Kong
NCT04286607	Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis	completed	PHASE3	333	Arcutis Biotherapeutics, Inc.
NCT04069312	Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)	completed	PHASE4	1,032	Johns Hopkins University
NCT04128007	Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis	completed	PHASE2	304	Arcutis Biotherapeutics, Inc.
NCT04211363	Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis	completed	PHASE3	439	Arcutis Biotherapeutics, Inc.
NCT03988816	Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis	unknown	PHASE2	30	University of Sao Paulo General Hospital
NCT04091646	Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis	completed	PHASE2	226	Arcutis Biotherapeutics, Inc.
NCT04090294	Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis	unknown	EARLY_PHASE1	35	Assiut University
NCT03916081	Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis	completed	PHASE2	136	Arcutis Biotherapeutics, Inc.
NCT04108377	Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma	terminated	PHASE1	5	University of California, Davis
NCT03764475	Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis	completed	PHASE2	332	Arcutis Biotherapeutics, Inc.
NCT03638258	The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis	completed	PHASE2	331	Arcutis Biotherapeutics, Inc.
NCT03532490	Trial of Roflumilast in Asthma Management (TRIM)	completed	PHASE2	38	Johns Hopkins University
NCT03458546	Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma	completed	PHASE1	14	The University of Texas Health Science Center at San Antonio
NCT03428334	Roflumilast in Non-CF Bronchiectasis Study	completed	PHASE2	20	The University of Hong Kong
NCT02743377	PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome	completed	PHASE1/PHASE2	16	National Institute of Mental Health (NIMH)
NCT06643221	Exercise as an Immune Adjuvant for Allogeneic Cell Therapies	recruiting	EARLY_PHASE1	200	University of Arizona
NCT02835716	Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO	unknown	N/A	150	Millennium Magnetic Technologies, LLC
NCT02671942	A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients	terminated	PHASE2	55	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NCT02451540	Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging	terminated	PHASE2	13	FLUIDDA nv
NCT04122547	Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis	completed	PHASE3	40	Prince of Songkla University
NCT02340520	Enhancement of Corticosteroid Efficacy in COPD	completed	PHASE3	13	UConn Health
NCT02165826	Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD	completed	PHASE3	1,323	AstraZeneca
NCT02187250	PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome	completed	PHASE4	45	University Medical Centre Ljubljana
NCT02079844	Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia	completed	PHASE1	20	Takeda
NCT02051335	Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults	completed	PHASE1	27	AstraZeneca
NCT02018432	Strategy to Improve Adherence of Roflumilast	unknown	PHASE4	80	Asan Medical Center
NCT03381573	Long-term Observational Study of the Safety of Roflumilast	completed	N/A	135,856	AstraZeneca
NCT01973998	Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization	completed	PHASE3	68	Temple University
NCT02037672	PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome	completed	PHASE4	36	University Medical Centre Ljubljana
NCT01888952	Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)	completed	EARLY_PHASE1	10	Anand B. Karnad
NCT01703260	Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis	terminated	PHASE2	20	AstraZeneca
NCT01856764	Topical Roflumilast in Adults With Atopic Dermatitis	completed	PHASE2	40	AstraZeneca
NCT01862029	Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals	completed	PHASE1/PHASE2	24	National Heart, Lung, and Blood Institute (NHLBI)
NCT01830959	Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)	unknown	PHASE4	50	University of Cincinnati
NCT03073798	The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis	completed	PHASE4	12	Johns Hopkins University
NCT01701934	Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease	terminated	PHASE2	14	Laval University
NCT02097992	Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD	completed	PHASE1/PHASE2	11	University of Miami
NCT01765192	Roflumilast Plus Montelukast in Adults With Severe Asthma	completed	PHASE2	64	AstraZeneca
NCT01745848	Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD	completed	PHASE4	26	University of Pittsburgh
NCT01730404	Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients	completed	PHASE2	55	Chiesi Farmaceutici S.p.A.
NCT02068456	Post Marketing Surveillance of Roflumilast in Korea	completed	N/A	1,837	AstraZeneca
NCT01664624	Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes	completed	PHASE1	40	AstraZeneca
NCT01849341	Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily	completed	PHASE4	105	Fundación Pública Andaluza Progreso y Salud
NCT01572948	A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)	completed	NA	27	University of Alabama at Birmingham
NCT01630200	Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)	completed	PHASE4	80	LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
NCT01595750	Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease	unknown	PHASE4	150	Spanish Research Center for Respiratory Diseases
NCT01580748	Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients	unknown	PHASE2	25	Seoul National University Bundang Hospital
NCT01473758	Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease	terminated	PHASE2	81	AstraZeneca
NCT01509677	Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease	completed	PHASE3	158	AstraZeneca
NCT01480661	Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients	completed	PHASE4	41	FLUIDDA nv
NCT01433666	Roflumilast and Cognition	completed	PHASE2	22	Maastricht University Medical Center
NCT01443845	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	completed	PHASE4	2,354	AstraZeneca
NCT01354782	Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects	completed	PHASE1	32	AstraZeneca
NCT01329029	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)	completed	PHASE4	1,945	AstraZeneca
NCT01313494	A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:	completed	PHASE3	626	AstraZeneca
NCT00746434	A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis	withdrawn	PHASE2	0	AstraZeneca
NCT00746382	A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)	withdrawn	PHASE2	0	AstraZeneca
NCT00424268	Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)	completed	PHASE3	743	AstraZeneca
NCT01140542	Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study	completed	PHASE2	487	AstraZeneca
NCT00313209	Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)	completed	PHASE3	933	AstraZeneca
NCT00297115	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)	completed	PHASE3	1,568	AstraZeneca
NCT00297102	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)	completed	PHASE3	1,523	AstraZeneca
NCT00242320	Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)	completed	PHASE3	551	AstraZeneca
NCT00246935	Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)	completed	PHASE3	150	AstraZeneca
NCT01365533	A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma	completed	PHASE2	48	AstraZeneca
NCT00246922	Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).	completed	PHASE3	150	AstraZeneca
NCT00242294	Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)	completed	PHASE2/PHASE3	570	AstraZeneca
NCT00108823	The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)	completed	PHASE3	550	AstraZeneca
NCT00163475	Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)	completed	PHASE3	511	AstraZeneca
NCT00242307	Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).	completed	PHASE2/PHASE3	450	AstraZeneca
NCT00940329	Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol	completed	PHASE1	27	AstraZeneca
NCT00076076	The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)	completed	PHASE3	822	AstraZeneca
NCT00076089	OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)	completed	PHASE3	1,100	AstraZeneca
NCT00073177	Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)	completed	PHASE3	819	AstraZeneca
NCT00062582	Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)	completed	PHASE3	1,000	AstraZeneca
NCT00163527	Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)	completed	PHASE3	2,054	AstraZeneca
NCT00430729	Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)	completed	PHASE3	1,100	AstraZeneca

Where to Participate: All Roflumilast Trial Sites in the U.S. (9 sites across 4 states)

Every actively recruiting Roflumilasttrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

State	Facility	City	Trial	Map
AZ	The University of Arizona	Tucson85719	NCT06643221	Map
LA	Lakeview Hospital	Covington70433	NCT07077902	Map
LA	Lakeside Hospital	New Orleans70001	NCT07077902	Map
LA	LCMC Multi-speciality Clinic	New Orleans70112	NCT07077902	Map
LA	University Medical Center	New Orleans70112	NCT07077902	Map
MA	Beth Israel Deaconess Medical Center	Boston02215	NCT07263230	Map
TX	Derm Texas	Dallas75235	NCT07105254	Map
TX	University Hospital System	San Antonio78228	NCT06977711	Map
TX	University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center	San Antonio78229	NCT06977711	Map

Browse Roflumilast Trials by State

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Data sourced from the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI). Report generated June 2, 2026.

What Is Roflumilast?

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Roflumilast Development Timeline

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All Roflumilast Clinical Trials (119)

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Where to Participate: All Roflumilast Trial Sites in the U.S. (9 sites across 4 states)

Browse Roflumilast Trials by State