NCT02451540

Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging. In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4. The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component. Image 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
RADIATION	HRCT scan	HRCT scan of thorax, at baseline and after 3 months
DRUG	Placebo of Roflumilast	Placebo, once a day in the morning during 3 months
DRUG	Roflumilast	Roflumilast, once a day in the morning during 3 months

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2015-05-22
• Last updated: 2018-03-21

Locations

1 site across 1 country: Belgium