drugset / Trial / NCT03073798

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

NCT03073798

Phase 4 Completed 12 enrolled Johns Hopkins University
RandomizedCrossoverQuadruple-blindTreatment

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

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule 500 ug