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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Roflumilast; Radiation: Functional Respiratory Imaging; Drug: Placebo of Roflumilast

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Radiation: Functional Respiratory Imaging; CT scan of thorax, at baseline and after 6 months; Drug: Placebo of Roflumilast; Placebo 500 µg, once a day in the morning during 6 months
Active Comparator: Roflumilast	Drug: Roflumilast; Roflumilast 500 µg, once a day in the morning during 6 months; Other Names: Daxas®; Radiation: Functional Respiratory Imaging; CT scan of thorax, at baseline and after 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: FLUIDDA nv
• Investigators: Principal Investigator: Lieven Bedert, MD, ZNA Middelheim

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Pulmonary Disease, Chronic Obstructive; Health Related Quality of Life; Roflumilast; Functional Respiratory Imaging; Computed Tomography scan
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: FLUI-2011-77; 2011-004271-36 (EudraCT Number)