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

NCT ID: NCT01480661

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Pulmonary Disease, Chronic Obstructive Computed Tomography scan Functional Respiratory Imaging Roflumilast Health Related Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Roflumilast

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

Roflumilast 500 µg, once a day in the morning during 6 months

Functional Respiratory Imaging

Intervention Type RADIATION

CT scan of thorax, at baseline and after 6 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo of Roflumilast

Intervention Type DRUG

Placebo 500 µg, once a day in the morning during 6 months

Functional Respiratory Imaging

Intervention Type RADIATION

CT scan of thorax, at baseline and after 6 months

Interventions

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Roflumilast

Roflumilast 500 µg, once a day in the morning during 6 months

Intervention Type DRUG

Placebo of Roflumilast

Placebo 500 µg, once a day in the morning during 6 months

Intervention Type DRUG

Functional Respiratory Imaging

CT scan of thorax, at baseline and after 6 months

Intervention Type RADIATION

Other Intervention Names

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Daxas®

Eligibility Criteria

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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.

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).
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FLUIDDA nv

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wilfried De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Lieven Bedert, MD

Role: PRINCIPAL_INVESTIGATOR

ZNA Middelheim

Locations

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ZNA Middelheim

Antwerp, Antwerp, Belgium

Site Status

Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2011-004271-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FLUI-2011-77

Identifier Type: -

Identifier Source: org_study_id