NCT01480661

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

Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Roflumilast	Roflumilast 500 µg, once a day in the morning during 6 months
DRUG	Placebo of Roflumilast	Placebo 500 µg, once a day in the morning during 6 months
RADIATION	Functional Respiratory Imaging	CT scan of thorax, at baseline and after 6 months

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-11-29
• Last updated: 2013-09-19

Locations

2 sites across 1 country: Belgium