drugset / Trial / NCT01480661

Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

NCT01480661

Phase 4 Completed 41 enrolled FLUIDDA nv
RandomizedParallel-groupTriple-blind

Summary

In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV. Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.

Timeline

Start
2011-12
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule 500 ug Oral