The Effectiveness of Roflumilast in Improving Mucociliary Clearance in Patients With COPD and Chronic Bronchitis
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.
Timeline
- Start
- 2013-03-18
- Primary completion
- 2015-05-14
- Completion
- 2015-05-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Roflumilast | Small molecule | 500 ug | — |