Clinical trial NCT01480661: Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients
Official title: Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Computed Tomography scan
Functional Respiratory Imaging
Roflumilast
Health Related Quality of Life
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Changes in airway geometry and function using CT based functional respiratory imaging.
timeFrame: At baseline and after 6 months of treatment
Secondary outcomes:
measure: Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)
timeFrame: At baseline and after 6 months of treatment
measure: Health related quality of life
timeFrame: At baseline and after 6 months of treatment
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Antwerp
country: Belgium
facility: ZNA Middelheim
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ZNA Middelheim
name: Lieven Bedert, MD
role: PRINCIPAL_INVESTIGATOR
References: