The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
Condition: COPD; Chronic Bronchitis; Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Emphysema; Acute Disease
Intervention: Roflumilast; Placebo
Intervention description: 500 mcg of Roflumilast which is a prescription medicine used in adults with severe COPD to decrease the number of flare-ups or the worsening of COPD symptoms; 500 mcg of placebo is used
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Lung Disease; Breathing Difficulty; Smoking; Mucociliary

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.
    

Eligibility 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.