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

Sponsor
Assiut University
Study ID
NCT04090294
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast is a phosphodiesterase (PDE) type 4 inhibitor will be prescribed for three month for the study group. the patients will then be assessed for improvement regarding exacerbation frequency , performance and pulmonary function test. patients will receive Roflumilast 500 Mcg. Tablet once daily for three months

Study Details

Aim of the work Assessment of early outcome of using Roflumilast in patients with bronchiectasis regarding: * Severity of symptoms * Frequency of exacerbations * Change in pulmonary function * Systemic inflammation

Key Dates

Start date
Oct 1, 2019
Status verified
Sep 2019
Primary completion
Sep 30, 2020
Completion
Nov 30, 2020

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast -non roflumilast
    35 patients will receive Roflumilast for three months and improvement regarding dyspnea scales , Pulmonary function Test , Six minutes walking test and bronchectasis severity index (FACED) score pre and post therapy will be assessed. patients will receive Roflumilast 500 Mcg. Tablet Once daily for Three months and then base line assessment will be repeated to evaluate improvement.

Primary Outcome Measure

Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]

Central Contacts

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