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

Sponsor
FLUIDDA nv
Study ID
NCT02451540
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HRCT scan — RADIATION
    HRCT scan of thorax, at baseline and after 3 months
  • Placebo of Roflumilast — DRUG
    Placebo, once a day in the morning during 3 months
  • Roflumilast — DRUG
    Roflumilast, once a day in the morning during 3 months

Study Details

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.

Key Dates

Start date
Sep 30, 2015
Status verified
Mar 2018
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment
  • Placebo Comparator: Placebo
    Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

Primary Outcome Measure

Changes in Airway volume (iVaw) [ Time Frame: At baseline and after 3 months of treatment ]

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