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

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo of Roflumilast; Drug: Roflumilast; Radiation: Functional Respiratory Imaging

• Registration Number: NCT01480661
• Lead Sponsor: FLUIDDA nv

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Study Start: 2011-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Male or female patient ≥ 30 years old
• Patient with BMI ≥ 20
• Written informed consent obtained
• Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
• Patient should be treated according to GOLD guidelines
• COPD patient with GOLD stages III until IV
• Patient with smoking history of at least 10 pack-years
• Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1
• Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.

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Exclusion Criteria

• Pregnant or lactating females
• Patient with severe immunological diseases and/ or severe acute infectious diseases.
• Patient with heart failure
• Patient with diagnosis of cancer (except basal cell carcinoma)
• Patient with a history of depression associated with suicidal ideation or behaviour
• Patient with moderate or severe hepatic impairment.
• Patient with lactose intolerance
• Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
• Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo of Roflumilast	-
Roflumilast	Roflumilast	-
Roflumilast	Functional Respiratory Imaging	-
Placebo	Functional Respiratory Imaging	-

Primary Outcome Measures

Name	Time	Method
Changes in airway geometry and function using CT based functional respiratory imaging.	At baseline and after 6 months of treatment	The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®.

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	At baseline and after 6 months of treatment	Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment.
Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)	At baseline and after 6 months of treatment	Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment.

Trial Locations

Locations (2)

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium