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

Sponsor
FLUIDDA nv
Study ID
NCT01480661
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2011
Status verified
Sep 2013
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Active Comparator: Roflumilast
  • Placebo Comparator: Placebo

Primary Outcome Measure

Changes in airway geometry and function using CT based functional respiratory imaging. [ Time Frame: At baseline and after 6 months of treatment ]

Related Studies