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

• Status: Completed
• Trial end date: 2015-05-14
• Target enrollment: 0
• Participant gender: All

Summary

Specific Aim: To determine the effectiveness of Roflumilast in improving i) whole right lung and ii) peripheral right lung mucociliary clearance (MCC) in patients with COPD and chronic bronchitis.

Hypothesis: Roflumilast increases mucociliary clearance in patients with chronic bronchitis.

Study Design: This will be a double-blinded, cross-over randomized controlled trial with 1:1 randomization of 20 individuals with chronic bronchitis. Subjects will undergo baseline MCC then will be randomized to either roflumilast or placebo x 4 weeks, then there will be a 4 week wash-out phase and a second 4 week period of roflumilast/placebo depending on initial randomization. MCC will be conducted at baseline and at the end of each 4 week medication phase.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University

Criteria

Inclusion Criteria:

• Physician diagnosis of COPD

• Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) ≤70%

• FEV1 (% predicted) ≥40 % AND ≤ 70%,

• Tobacco exposure ≥ 10 pack-years,

• Chronic cough and sputum production

• At least one COPD exacerbation requiring systemic glucocorticosteroids or treatment in hospital, or both, in the previous year

• Not suffering from any concomitant disease that might interfere with study procedures or evaluations.

Exclusion Criteria:

• COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit V0

• Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0

• Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis

• Known alpha-1-antitrypsin deficiency

• Known infection with HIV and/or active hepatitis

• Pregnancy or women of childbearing potential not using or willing to continue using a medically reliable method of contraception for the entire study period

• Suspected hypersensitivity to the study medication (roflumilast).

• Use of mucolytics within the last 4 weeks.