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

Sponsor
Johns Hopkins University
Study ID
NCT03073798
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    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
  • Placebo — DRUG
    500 mcg of placebo is used

Study Details

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.

Key Dates

Start date
Mar 18, 2013
Status verified
Jun 2017
Primary completion
May 14, 2015
Completion
May 14, 2015

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Medication
    Roflumilast. 500 mcg of Roflumilast daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of placebo.
  • Placebo Comparator: Placebo
    Placebo. 500 mcg of Placebo daily for 4 weeks, then there will be a 4 week wash-out phase (no medication) and a second 4 week period of Roflumilast

Primary Outcome Measure

Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A [ Time Frame: Change from 0 to 30 minutes ]

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