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

NCT01480661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-09-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • FLUIDDA nv

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, MD, PhD · University Hospital, Antwerp

  • Lieven Bedert, MD · ZNA Middelheim

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01480661 on ClinicalTrials.gov