Roflumilast Clinical Trials (2026): 119 Studies for COPD & Chronic Obstructive Pulmonary Disease
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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119 Roflumilast clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 66 indications (including COPD & Chronic Obstructive Pulmonary Disease) and 173,452 total planned enrollment. 36 Phase 3 Roflumilast trials and 38 Phase 2, 19 Phase 4 are listed. 14 Roflumilast clinical trials are actively recruiting at 9 U.S. sites across 4 states. Most recent activity: NCT06643221 (May 2031).
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 |
Roflumilast clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | 1 | 3 | ||||
| P1 | 1 | 1 | 6 | 1 | 2 | 11 | ||
| P1/P2 | 3 | 1 | 1 | 5 | ||||
| P2 | 6 | 1 | 19 | 5 | 2 | 2 | 3 | 38 |
| P2/P3 | 3 | 3 | ||||||
| P3 | 2 | 32 | 1 | 1 | 36 | |||
| P4 | 12 | 2 | 5 | 19 | ||||
| N/A | 3 | 1 | 4 |
Recruiting Roflumilast clinical trials (14)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06643221 | Allo-XExercise as an Immune Adjuvant for Allogeneic Cell Therapies | Early P1 | Leukemia | 200 | Jan 2018 |
| NCT07352566 | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis | P4 | Psoriasis | 10 | Aug 2026 |
| NCT07263230 | The Safety and Efficacy of Roflumilast Foam in HS | P2 | Hidradenitis Suppurativa (HS) | 20 | Apr 2026 |
| NCT07314242 | A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD | P2 | COPD (Chronic Obstructive Pulmonary Disease) | 120 | Jan 2026 |
| NCT07560618 | Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. | P4 | ITCH | 40 | Apr 2026 |
| NCT06860958 | Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients | P3 | Depressive Disorder, Major | 60 | Mar 2025 |
| NCT07566351 | Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis | P2 | Rheumatoid Arthritis | 90 | Apr 2026 |
| NCT07077902 | A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa | P2 | Hidradenitis Suppurativa | 10 | Sep 2025 |
| NCT07543640 | EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. | P2 | Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis | 56 | Apr 2026 |
| NCT06977711 | DLBCLLoncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) | P1 | Diffuse Large B-cell Lymphoma | 10 | Jun 2025 |
| NCT07105254 | NSVAn Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) | P2 | Non-segmental Vitiligo | 20 | Aug 2025 |
| NCT07297602 | ROFLU-AD12Evaluation 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 | P2 | Atopic Dermatitis | 36 | Nov 2025 |
| NCT07233291 | PSOROFLUA Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults | P2 | Psoriasis (PsO) | 36 | Aug 2025 |
| NCT06648772 | Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study | P3 | Plaque Psoriasis | 189 | Nov 2024 |
Roflumilast clinical trials by indication
Chronic Obstructive Pulmonary Disease (13)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04636814 | PILLAR | P3 | terminated | 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) |
| NCT02671942 | — | P2 | terminated | A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients |
| NCT02068456 | — | N/A | completed | Post Marketing Surveillance of Roflumilast in Korea |
| NCT01745848 | — | P4 | completed | Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD |
| NCT02018432 | — | P4 | unknown | Strategy to Improve Adherence of Roflumilast |
| NCT01701934 | RAMBO | P2 | terminated | Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease |
| NCT01329029 | REACT | P4 | completed | Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS) |
| NCT01595750 | REVASC | P4 | unknown | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease |
| + 5 more, see All trials below. | ||||
COPD (11)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03381573 | — | N/A | completed | Long-term Observational Study of the Safety of Roflumilast |
| NCT01973998 | — | P3 | completed | Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization |
| NCT02340520 | — | P3 | completed | Enhancement of Corticosteroid Efficacy in COPD |
| NCT01509677 | — | P3 | completed | Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease |
| NCT01443845 | COPD | P4 | completed | Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) |
| NCT02097992 | — | P1/P2 | completed | Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD |
| NCT03073798 | — | P4 | completed | The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis |
| NCT01572948 | COPD | N/A | completed | A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD) |
| + 3 more, see All trials below. | ||||
Asthma (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04108377 | — | P1 | terminated | Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma |
| NCT03532490 | TRIM | P2 | completed | Trial of Roflumilast in Asthma Management (TRIM) |
| NCT01765192 | — | P2 | completed | Roflumilast Plus Montelukast in Adults With Severe Asthma |
| NCT00163527 | — | P3 | completed | Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) |
| NCT00163475 | — | P3 | completed | Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015) |
| NCT00076076 | — | P3 | completed | The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023) |
| NCT00073177 | — | P3 | completed | Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012) |
Chronic Obstructive Pulmonary Disease (COPD) (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02165826 | OPTIMIZE | P3 | completed | Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD |
| NCT01849341 | ROFLU2011 | P4 | completed | Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily |
| NCT00297102 | COPD | P3 | completed | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124) |
| NCT00297115 | COPD | P3 | completed | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125) |
| NCT00313209 | EOS | P3 | completed | Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) |
| NCT00246935 | APTA-2217-08 | P3 | completed | Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08) |
| NCT00242294 | APTA-2217-06 | P2/P3 | completed | Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06) |
Plaque Psoriasis (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06648772 | — | P3 | recruiting | Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study |
| NCT05763082 | — | P3 | completed | Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis |
| NCT03764475 | — | P2 | completed | Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis |
| NCT04128007 | — | P2 | completed | Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis |
| NCT03638258 | ARQ-151-201 | P2 | completed | The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis |
| NCT00746434 | — | P2 | withdrawn | A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis |
Psoriasis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07352566 | — | P4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05684744 | — | P2/P3 | completed | Roflumilast Versus Methotrexate in Psoriasis |
| NCT04549870 | PSORRO | P2 | completed | Efficacy of Roflumilast in the Treatment of Psoriasis |
Atopic Dermatitis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07297602 | ROFLU-AD12 | P2 | recruiting | 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 |
| NCT03916081 | — | P2 | completed | Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis |
| NCT01856764 | — | P2 | completed | Topical Roflumilast in Adults With Atopic Dermatitis |
Atopic Dermatitis Eczema (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04845620 | — | P3 | completed | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED) |
| NCT04773600 | INTEGUMENT-II | P3 | completed | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) |
| NCT04773587 | INTEGUMENT-I | P3 | completed | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis |
Lymphoma, B-Cell (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05796271 | — | P1 | withdrawn | Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy |
| NCT03458546 | — | P1 | completed | Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma |
Seborrheic Dermatitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04973228 | ARQ-154 | P3 | completed | Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM) |
| NCT04091646 | — | P2 | completed | Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis |
Obesity (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04800172 | — | P3 | completed | The Possible Effects of Roflumilast on Obesity Related Disorders |
| NCT01862029 | — | P1/P2 | completed | Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals |
Non-cystic Fibrosis Bronchiectasis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04322929 | — | P2 | completed | Roflumilast in Non-CF Bronchiectasis Study (2019) |
| NCT03428334 | — | P2 | completed | Roflumilast in Non-CF Bronchiectasis Study |
Chronic Plaque Psoriasis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04286607 | DERMIS-OLE | P3 | completed | Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis |
| NCT04211363 | DERMIS-1 | P3 | completed | Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis |
Pulmonary Disease, Chronic Obstructive (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02451540 | — | P2 | terminated | Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging |
| NCT01480661 | — | P4 | completed | Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients |
PCOS (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02187250 | — | P4 | completed | PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome |
| NCT02037672 | — | P4 | completed | PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome |
Bronchial Asthma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00246922 | APTA-2217-07 | P3 | completed | Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07). |
| NCT00242307 | APTA-2217-05 | P2/P3 | completed | Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05). |
ITCH (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07560618 | — | P4 | not yet recruiting | Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. |
Rheumatoid Arthritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07566351 | — | P2 | recruiting | Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis |
Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07543640 | — | P2 | not yet recruiting | EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. |
Hidradenitis Suppurativa (HS) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07263230 | — | P2 | recruiting | The Safety and Efficacy of Roflumilast Foam in HS |
COPD (Chronic Obstructive Pulmonary Disease) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07314242 | — | P2 | not yet recruiting | A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD |
Hidradenitis Suppurativa (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07077902 | — | P2 | recruiting | A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa |
Psoriasis (PsO) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07233291 | PSOROFLU | P2 | recruiting | A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults |
Non-segmental Vitiligo (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07105254 | NSV | P2 | recruiting | 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) |
Diffuse Large B-cell Lymphoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06977711 | DLBCL | P1 | recruiting | Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) |
Depressive Disorder, Major (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06860958 | — | P3 | recruiting | Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
Alopecia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07174011 | AA | P4 | completed | Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata |
Atopic Dermatitis (AD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06631170 | — | P3 | completed | Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis |
Other Conditions of Brain (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06457191 | — | P1 | active not recruiting | Roflumilast and TMS Motor Plasticity |
Healthy Skin (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06440473 | — | P4 | unknown | Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin |
Chronic Hand Eczema (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05682859 | HERO | P4 | unknown | Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) |
Peripheral Neuropathy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05884281 | — | P1/P2 | unknown | Efficacy of Roflumilast in Prevention of Peripheral Neuropathy |
Ulcerative Colitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05684484 | — | P4 | completed | Role of Roflumilast in Ulcerative Colitis |
Fragile X Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05418049 | — | P2 | active not recruiting | Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge |
Type 2 Diabetes (Adult Onset) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05369793 | — | P3 | completed | Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy |
Rosacea (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05278624 | — | P2 | completed | Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea |
Non-Alcoholic Steatohepatitis (NASH) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06677788 | — | P2 | completed | Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH |
Synaptic Plasticity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04369547 | — | P1 | withdrawn | Roflumilast TMS-EEG Plasticity |
Mild Cognitive Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04658654 | ROMEMA | P2 | unknown | Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients |
Scalp Psoriasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05028582 | ARRECTOR | P3 | completed | Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) |
Cerebrovascular Disorders (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04854811 | ROSTMEMA | P2 | completed | Roflumilast to Treat Cognitive Sequela After Stroke |
Respiratory Distress Syndrome, Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04744090 | — | P2 | completed | Roflumilast as add-on Therapy in Early Cases of ARDS |
Diabetic Nephropathies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04755946 | — | P3 | unknown | Possible Role of Roflumilast in Diabetic Nephropathy |
Major Depressive Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04751071 | — | P1/P2 | withdrawn | The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
Chronic Obstructive Pulmonary Disease Severe (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04069312 | RELIANCE | P4 | completed | Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) |
Bronchiectasis Adult (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03988816 | — | P2 | unknown | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis |
Bronchiectasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04090294 | — | Early P1 | unknown | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis |
Nervous System Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02743377 | PDE4 | P1/P2 | completed | PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome |
Leukemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06643221 | Allo-X | Early P1 | recruiting | Exercise as an Immune Adjuvant for Allogeneic Cell Therapies |
Alzheimer Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02835716 | PCD=OOALZ | N/A | unknown | Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO |
Exacerbation Copd (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04122547 | — | P3 | completed | Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis |
Schizophrenia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02079844 | — | P1 | completed | Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia |
Memory Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02051335 | — | P1 | completed | Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults |
Advanced B-cell Lymphoid Malignancies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01888952 | — | Early P1 | completed | Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013) |
Nonalcoholic Steatohapatitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01703260 | — | P2 | terminated | Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis |
Sarcoidosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01830959 | REFS | P4 | unknown | Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS) |
Type 2 Diabetes (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01664624 | — | P1 | completed | Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes |
Chronic Obstructive Pulmonary Disease and Allied Conditions (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01630200 | ELASTIC | P4 | completed | Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD) |
Symptomatic Bronchiectasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01580748 | — | P2 | unknown | Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients |
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01473758 | TREAT | P2 | terminated | Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease |
Dementia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01433666 | EEGrofl | P2 | completed | Roflumilast and Cognition |
Dermatitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00746382 | RO-2351-001-EM | P2 | withdrawn | A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM) |
Diabetes Mellitus Type 2 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01140542 | FORTUNA | P2 | completed | 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 |
Allergic Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01365533 | — | P2 | completed | A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma |
Chronic Obstructive Pulmonary Disease, COPD (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00108823 | — | P3 | completed | The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121) |
Healthy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00940329 | — | P1 | completed | Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol |
Roflumilast pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| HERO | NCT05682859 | P4 | unknown | Chronic Hand Eczema | 40 | — |
| RELIANCE | NCT04069312 | P4 | completed | Chronic Obstructive Pulmonary Disease Severe | 1,032 | — |
| AA | NCT07174011 | P4 | completed | Alopecia | 50 | — |
| REFS | NCT01830959 | P4 | unknown | Sarcoidosis | 50 | PMID 34744427 |
| ELASTIC | NCT01630200 | P4 | completed | Chronic Obstructive Pulmonary Disease and Allied Conditions | 80 | PMID 32725799 |
| COPD | NCT01443845 | P4 | completed | COPD | 2,354 | PMID 27585384 |
| ROFLU2011 | NCT01849341 | P4 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 105 | — |
| REACT | NCT01329029 | P4 | completed | Chronic Obstructive Pulmonary Disease | 1,945 | PMID 28679611 |
| REVASC | NCT01595750 | P4 | unknown | Chronic Obstructive Pulmonary Disease | 150 | — |
| PILLAR | NCT04636814 | P3 | terminated | Chronic Obstructive Pulmonary Disease | 3,973 | — |
| DERMIS-OLE | NCT04286607 | P3 | completed | Chronic Plaque Psoriasis | 333 | — |
| INTEGUMENT-II | NCT04773600 | P3 | completed | Atopic Dermatitis Eczema | 683 | PMID 39292443 |
| INTEGUMENT-I | NCT04773587 | P3 | completed | Atopic Dermatitis Eczema | 654 | — |
| ARRECTOR | NCT05028582 | P3 | completed | Scalp Psoriasis | 432 | PMID 40332898 |
| ARQ-154 | NCT04973228 | P3 | completed | Seborrheic Dermatitis | 457 | — |
| DERMIS-1 | NCT04211363 | P3 | completed | Chronic Plaque Psoriasis | 439 | PMID 36422852 |
| OPTIMIZE | NCT02165826 | P3 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 1,323 | — |
| ACROSS | NCT01313494 | P3 | completed | COPD | 626 | PMID 24135893 |
| COPD | NCT00297102 | P3 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 1,523 | PMID 23117188 |
| COPD | NCT00297115 | P3 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 1,568 | PMID 19716960 |
| HELIOS | NCT00424268 | P3 | completed | Chronic Obstructive Pulmonary Disease | 743 | PMID 19716961 |
| EOS | NCT00313209 | P3 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 933 | — |
| APTA-2217-08 | NCT00246935 | P3 | completed | Chronic Obstructive Pulmonary Disease (COPD) | 150 | — |
| APTA-2217-07 | NCT00246922 | P3 | completed | Bronchial Asthma | 150 | — |
| COPD | NCT00062582 | P3 | completed | Chronic Obstructive Pulmonary Disease | 1,000 | — |
| NSV | NCT07105254 | P2 | recruiting | Non-segmental Vitiligo | 20 | — |
| ROFLU-AD12 | NCT07297602 | P2 | recruiting | Atopic Dermatitis | 36 | — |
| PSOROFLU | NCT07233291 | P2 | recruiting | Psoriasis (PsO) | 36 | — |
| ROSTMEMA | NCT04854811 | P2 | completed | Cerebrovascular Disorders | 100 | — |
| ROMEMA | NCT04658654 | P2 | unknown | Mild Cognitive Impairment | 81 | PMID 38438923 |
| PSORRO | NCT04549870 | P2 | completed | Psoriasis | 46 | PMID 37465323 |
| TRIM | NCT03532490 | P2 | completed | Asthma | 38 | PMID 36170654 |
| ARQ-151-201 | NCT03638258 | P2 | completed | Plaque Psoriasis | 331 | PMID 36370336 |
| RAMBO | NCT01701934 | P2 | terminated | Chronic Obstructive Pulmonary Disease | 14 | PMID 12654609 |
| TREAT | NCT01473758 | P2 | terminated | Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation | 81 | PMID 28146642 |
| EEGrofl | NCT01433666 | P2 | completed | Dementia | 22 | PMID 29241652 |
| RO-2351-001-EM | NCT00746382 | P2 | withdrawn | Dermatitis | 0 | — |
| FORTUNA | NCT01140542 | P2 | completed | Diabetes Mellitus Type 2 | 487 | — |
Terminated and withdrawn Roflumilast trials (12)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05796271withdrawnClinical Trial of Roflumilast Added to Standard Chemoimmunotherapy
- NCT04636814terminatedA 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)
- NCT04751071withdrawnThe Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients
- NCT04369547withdrawnRoflumilast TMS-EEG Plasticity
- NCT04108377terminatedPhosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
- NCT02671942terminatedA Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
- NCT02451540terminatedEvaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
- NCT01701934terminatedImpact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease
- NCT01703260terminatedSafety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
- NCT01473758terminatedEffect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
- NCT00746434withdrawnA Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis
- NCT00746382withdrawnA Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)
All Roflumilast trials (119)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06643221 | Allo-X | Exercise as an Immune Adjuvant for Allogeneic Cell Therapies | Early P1 | recruiting | 200 | University of Arizona | Jan 2018 |
| NCT07352566 | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis | P4 | not yet recruiting | 10 | University of California, San Francisco | Aug 2026 | |
| NCT07263230 | The Safety and Efficacy of Roflumilast Foam in HS | P2 | recruiting | 20 | Beth Israel Deaconess Medical Center | Apr 2026 | |
| NCT05796271 | Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy | P1 | withdrawn | 0 | The University of Texas Health Science Center at San Antonio | Jan 2024 | |
| NCT07314242 | A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD | P2 | not yet recruiting | 120 | Ganzhou Hemay Pharmaceutical Co., Ltd | Jan 2026 | |
| NCT07560618 | Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. | P4 | not yet recruiting | 40 | Integrative Skin Science and Research | Apr 2026 | |
| NCT06860958 | Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients | P3 | recruiting | 60 | Tanta University | Mar 2025 | |
| NCT07566351 | Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis | P2 | recruiting | 90 | Horus University | Apr 2026 | |
| NCT07077902 | A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa | P2 | recruiting | 10 | Tulane University | Sep 2025 | |
| NCT07543640 | EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. | P2 | not yet recruiting | 56 | Eman Raafat Said | Apr 2026 | |
| NCT06977711 | DLBCL | Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) | P1 | recruiting | 10 | The University of Texas Health Science Center at San Antonio | Jun 2025 |
| NCT06457191 | Roflumilast and TMS Motor Plasticity | P1 | active not recruiting | 20 | University of Calgary | Nov 2024 | |
| NCT07105254 | NSV | 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) | P2 | recruiting | 20 | Derm Texas, PLLC | Aug 2025 |
| NCT07297602 | ROFLU-AD12 | 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 | P2 | recruiting | 36 | Nora Mohamed Abdelrazik | Nov 2025 |
| NCT05682859 | HERO | Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) | P4 | unknown | 40 | Jacob Pontoppidan Thyssen | Sep 2023 |
| NCT05418049 | Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge | P2 | active not recruiting | 45 | Children's Hospital Medical Center, Cincinnati | Sep 2022 | |
| NCT04069312 | RELIANCE | Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) | P4 | completed | 1,032 | Johns Hopkins University | Feb 2020 |
| NCT07233291 | PSOROFLU | A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults | P2 | recruiting | 36 | Ahmed Ibrahim | Aug 2025 |
| NCT04636814 | PILLAR | 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) | P3 | terminated | 3,973 | Chiesi Farmaceutici S.p.A. | Jul 2021 |
| NCT04751071 | The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients | P1/P2 | withdrawn | 0 | Sadat City University | Feb 2021 | |
| NCT07174011 | AA | Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata | P4 | completed | 50 | Cairo University | Jan 2025 |
| NCT06631170 | Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis | P3 | completed | 354 | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Nov 2024 | |
| NCT06648772 | Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study | P3 | recruiting | 189 | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Nov 2024 | |
| NCT04322929 | Roflumilast in Non-CF Bronchiectasis Study (2019) | P2 | completed | 42 | The University of Hong Kong | Nov 2020 | |
| NCT06677788 | Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH | P2 | completed | 55 | Tanta University | Apr 2022 | |
| NCT05684484 | Role of Roflumilast in Ulcerative Colitis | P4 | completed | 52 | Tanta University | Feb 2023 | |
| NCT06440473 | Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin | P4 | unknown | 3 | Rao Dermatology | May 2024 | |
| NCT04286607 | DERMIS-OLE | Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis | P3 | completed | 333 | Arcutis Biotherapeutics, Inc. | Feb 2020 |
| NCT03458546 | Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma | P1 | completed | 14 | The University of Texas Health Science Center at San Antonio | May 2018 | |
| NCT05884281 | Efficacy of Roflumilast in Prevention of Peripheral Neuropathy | P1/P2 | unknown | 60 | Mansoura University | Jul 2023 | |
| NCT04854811 | ROSTMEMA | Roflumilast to Treat Cognitive Sequela After Stroke | P2 | completed | 100 | Maastricht University | Jul 2021 |
| NCT04658654 | ROMEMA | Cognitive Effects of Roflumilast in (a)MCI and Mild Dementia Patients | P2 | unknown | 81 | Maastricht University Medical Center | Nov 2021 |
| NCT05369793 | Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy | P3 | completed | 60 | Tanta University | Aug 2022 | |
| NCT04369547 | Roflumilast TMS-EEG Plasticity | P1 | withdrawn | 0 | University of Calgary | Jan 2022 | |
| NCT04108377 | Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma | P1 | terminated | 5 | University of California, Davis | Jan 2019 | |
| NCT05763082 | Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis | P3 | completed | 414 | Padagis LLC | Feb 2023 | |
| NCT04845620 | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED) | P3 | completed | 652 | Arcutis Biotherapeutics, Inc. | Apr 2021 | |
| NCT05684744 | Roflumilast Versus Methotrexate in Psoriasis | P2/P3 | completed | 30 | Cairo University | Jan 2023 | |
| NCT05278624 | Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea | P2 | completed | 40 | Dermatology Consulting Services, PLLC | Apr 2022 | |
| NCT04549870 | PSORRO | Efficacy of Roflumilast in the Treatment of Psoriasis | P2 | completed | 46 | Bispebjerg Hospital | Jan 2021 |
| NCT04773600 | INTEGUMENT-II | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) | P3 | completed | 683 | Arcutis Biotherapeutics, Inc. | Feb 2021 |
| NCT03381573 | Long-term Observational Study of the Safety of Roflumilast | — | completed | 135,856 | AstraZeneca | Dec 2013 | |
| NCT04773587 | INTEGUMENT-I | Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis | P3 | completed | 654 | Arcutis Biotherapeutics, Inc. | Jan 2021 |
| NCT05028582 | ARRECTOR | Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR) | P3 | completed | 432 | Arcutis Biotherapeutics, Inc. | Aug 2021 |
| NCT04973228 | ARQ-154 | Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM) | P3 | completed | 457 | Arcutis Biotherapeutics, Inc. | Jul 2021 |
| NCT04800172 | The Possible Effects of Roflumilast on Obesity Related Disorders | P3 | completed | 66 | Tanta University | May 2021 | |
| NCT04744090 | Roflumilast as add-on Therapy in Early Cases of ARDS | P2 | completed | 76 | Cairo University | Mar 2021 | |
| NCT03532490 | TRIM | Trial of Roflumilast in Asthma Management (TRIM) | P2 | completed | 38 | Johns Hopkins University | Aug 2018 |
| NCT04755946 | Possible Role of Roflumilast in Diabetic Nephropathy | P3 | unknown | 48 | Tanta University | Mar 2021 | |
| NCT03988816 | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis | P2 | unknown | 30 | University of Sao Paulo General Hospital | Dec 2019 | |
| NCT04090294 | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis | Early P1 | unknown | 35 | Assiut University | Oct 2019 | |
| NCT04211363 | DERMIS-1 | Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis | P3 | completed | 439 | Arcutis Biotherapeutics, Inc. | Dec 2019 |
| NCT03764475 | Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis | P2 | completed | 332 | Arcutis Biotherapeutics, Inc. | Dec 2018 | |
| NCT02835716 | PCD=OOALZ | Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO | — | unknown | 150 | Millennium Magnetic Technologies, LLC | Sep 2016 |
| NCT04128007 | Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis | P2 | completed | 304 | Arcutis Biotherapeutics, Inc. | Jan 2020 | |
| NCT04091646 | Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis | P2 | completed | 226 | Arcutis Biotherapeutics, Inc. | Dec 2019 | |
| NCT02743377 | PDE4 | PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome | P1/P2 | completed | 16 | National Institute of Mental Health (NIMH) | Apr 2018 |
| NCT03916081 | Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis | P2 | completed | 136 | Arcutis Biotherapeutics, Inc. | May 2019 | |
| NCT03428334 | Roflumilast in Non-CF Bronchiectasis Study | P2 | completed | 20 | The University of Hong Kong | May 2018 | |
| NCT03638258 | ARQ-151-201 | The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis | P2 | completed | 331 | Arcutis Biotherapeutics, Inc. | Sep 2018 |
| NCT02671942 | A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients | P2 | terminated | 55 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Mar 2016 | |
| NCT01973998 | Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization | P3 | completed | 68 | Temple University | Nov 2013 | |
| NCT02451540 | Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging | P2 | terminated | 13 | FLUIDDA nv | Sep 2015 | |
| NCT01862029 | Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals | P1/P2 | completed | 24 | National Heart, Lung, and Blood Institute (NHLBI) | May 2013 | |
| NCT02068456 | Post Marketing Surveillance of Roflumilast in Korea | — | completed | 1,837 | AstraZeneca | Sep 2012 | |
| NCT01830959 | REFS | Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS) | P4 | unknown | 50 | University of Cincinnati | Apr 2013 |
| NCT02340520 | Enhancement of Corticosteroid Efficacy in COPD | P3 | completed | 13 | UConn Health | Dec 2014 | |
| NCT01745848 | Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD | P4 | completed | 26 | University of Pittsburgh | Feb 2013 | |
| NCT01509677 | Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease | P3 | completed | 158 | AstraZeneca | Feb 2012 | |
| NCT01630200 | ELASTIC | Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD) | P4 | completed | 80 | LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology | May 2012 |
| NCT01443845 | COPD | Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) | P4 | completed | 2,354 | AstraZeneca | Sep 2011 |
| NCT04122547 | Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis | P3 | completed | 40 | Prince of Songkla University | Jan 2015 | |
| NCT02018432 | Strategy to Improve Adherence of Roflumilast | P4 | unknown | 80 | Asan Medical Center | Dec 2013 | |
| NCT02165826 | OPTIMIZE | Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD | P3 | completed | 1,323 | AstraZeneca | May 2014 |
| NCT02097992 | Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD | P1/P2 | completed | 11 | University of Miami | Feb 2013 | |
| NCT02079844 | Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia | P1 | completed | 20 | Takeda | Mar 2014 | |
| NCT03073798 | The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis | P4 | completed | 12 | Johns Hopkins University | Mar 2013 | |
| NCT01888952 | Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013) | Early P1 | completed | 10 | Anand B. Karnad | Jul 2013 | |
| NCT01701934 | RAMBO | Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease | P2 | terminated | 14 | Laval University | Feb 2013 |
| NCT01703260 | Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis | P2 | terminated | 20 | AstraZeneca | Jun 2013 | |
| NCT01849341 | ROFLU2011 | Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily | P4 | completed | 105 | Fundación Pública Andaluza Progreso y Salud | Jul 2012 |
| NCT02187250 | PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome | P4 | completed | 45 | University Medical Centre Ljubljana | Mar 2014 | |
| NCT01572948 | COPD | A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD) | N/A | completed | 27 | University of Alabama at Birmingham | Jun 2012 |
| NCT02051335 | Roflumilast and Donepezil to Reverse Scopolamine Induced Cognitive Deficits in Healthy Adults | P1 | completed | 27 | AstraZeneca | Jan 2014 | |
| NCT01329029 | REACT | Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS) | P4 | completed | 1,945 | AstraZeneca | May 2011 |
| NCT01856764 | Topical Roflumilast in Adults With Atopic Dermatitis | P2 | completed | 40 | AstraZeneca | Jun 2013 | |
| NCT01473758 | TREAT | Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease | P2 | terminated | 81 | AstraZeneca | Feb 2012 |
| NCT02037672 | PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome | P4 | completed | 36 | University Medical Centre Ljubljana | Sep 2013 | |
| NCT01765192 | Roflumilast Plus Montelukast in Adults With Severe Asthma | P2 | completed | 64 | AstraZeneca | Feb 2013 | |
| NCT01730404 | Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients | P2 | completed | 55 | Chiesi Farmaceutici S.p.A. | Oct 2012 | |
| NCT01433666 | EEGrofl | Roflumilast and Cognition | P2 | completed | 22 | Maastricht University Medical Center | Sep 2011 |
| NCT01480661 | Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients | P4 | completed | 41 | FLUIDDA nv | Dec 2011 | |
| NCT01580748 | Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients | P2 | unknown | 25 | Seoul National University Bundang Hospital | May 2012 | |
| NCT01664624 | Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes | P1 | completed | 40 | AstraZeneca | Jul 2012 | |
| NCT01595750 | REVASC | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease | P4 | unknown | 150 | Spanish Research Center for Respiratory Diseases | May 2012 |
| NCT01313494 | ACROSS | A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore: | P3 | completed | 626 | AstraZeneca | Mar 2011 |
| NCT01354782 | Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects | P1 | completed | 32 | AstraZeneca | May 2011 | |
| NCT00746434 | A Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild to Moderate Plaque Psoriasis | P2 | withdrawn | 0 | AstraZeneca | Nov 2008 | |
| NCT00746382 | RO-2351-001-EM | A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM) | P2 | withdrawn | 0 | AstraZeneca | Nov 2008 |
| NCT00297102 | COPD | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124) | P3 | completed | 1,523 | AstraZeneca | Feb 2006 |
| NCT00297115 | COPD | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125) | P3 | completed | 1,568 | AstraZeneca | Mar 2006 |
| NCT00424268 | HELIOS | Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128) | P3 | completed | 743 | AstraZeneca | Jan 2007 |
| NCT01140542 | FORTUNA | 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 | P2 | completed | 487 | AstraZeneca | Aug 2006 |
| NCT00313209 | EOS | Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) | P3 | completed | 933 | AstraZeneca | Apr 2006 |
| NCT00246935 | APTA-2217-08 | Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08) | P3 | completed | 150 | AstraZeneca | May 2005 |
| NCT00246922 | APTA-2217-07 | Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07). | P3 | completed | 150 | AstraZeneca | Dec 2004 |
| NCT00242320 | Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119) | P3 | completed | 551 | AstraZeneca | Aug 2005 | |
| NCT00242307 | APTA-2217-05 | Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05). | P2/P3 | completed | 450 | AstraZeneca | May 2004 |
| NCT00242294 | APTA-2217-06 | Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06) | P2/P3 | completed | 570 | AstraZeneca | Nov 2004 |
| NCT00076089 | OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111) | P3 | completed | 1,100 | AstraZeneca | Dec 2003 | |
| NCT00163527 | Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) | P3 | completed | 2,054 | AstraZeneca | Apr 2003 | |
| NCT00163475 | Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015) | P3 | completed | 511 | AstraZeneca | May 2004 | |
| NCT01365533 | A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma | P2 | completed | 48 | AstraZeneca | Dec 2004 | |
| NCT00076076 | The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023) | P3 | completed | 822 | AstraZeneca | Dec 2003 | |
| NCT00940329 | Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol | P1 | completed | 27 | AstraZeneca | Apr 2004 | |
| NCT00108823 | The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121) | P3 | completed | 550 | AstraZeneca | Oct 2004 | |
| NCT00073177 | Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012) | P3 | completed | 819 | AstraZeneca | Nov 2003 | |
| NCT00062582 | COPD | Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110) | P3 | completed | 1,000 | AstraZeneca | Jun 2003 |
| NCT00430729 | Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112) | P3 | completed | 1,100 | AstraZeneca | Jan 2003 |
Roflumilast clinical trials: frequently asked questions
- How many Roflumilast clinical trials are there?
- 119 Roflumilast clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 10 are actively recruiting participants. 79 are marked completed.
- Are Roflumilast clinical trials recruiting in 2026?
- Yes — 10 Roflumilast trials are actively recruiting in 2026, with 9 U.S. sites across 4 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Roflumilast being studied for?
- Roflumilast is being studied for COPD, Chronic Obstructive Pulmonary Disease, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Plaque Psoriasis and 85 more. The trials are grouped by indication on this page.
- What phase is Roflumilast in?
- Roflumilast clinical trials span 19 Phase 4, 36 Phase 3, 38 Phase 2, 11 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Roflumilast clinical trials?
- The lead sponsor across the most Roflumilast trials is AstraZeneca, with 54 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Roflumilastas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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Related pages on Hipa.ai: