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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480661
• Other study ID #: FLUI-2011-77
• Secondary ID: 2011-004271-36
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: September 18, 2013
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerp
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in airway geometry and function using CT based functional respiratory imaging.	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®.	At baseline and after 6 months of treatment	No
Secondary	Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)	Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment.	At baseline and after 6 months of treatment	No
Secondary	Health related quality of life	Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment.	At baseline and after 6 months of treatment	No