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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01480661
First received: November 21, 2011
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Roflumilast
Drug: Placebo of Roflumilast
Radiation: Functional Respiratory Imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging

Resource links provided by NLM:


Further study details as provided by FluidDA nv:

Primary Outcome Measures:
  • Changes in airway geometry and function using CT based functional respiratory imaging. [ Time Frame: At baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
    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:
  • Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique) [ Time Frame: At baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
    Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment.

  • Health related quality of life [ Time Frame: At baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
    Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment.


Enrollment: 41
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roflumilast Drug: Roflumilast
Roflumilast 500 µg, once a day in the morning during 6 months
Other Name: Daxas®
Radiation: Functional Respiratory Imaging
CT scan of thorax, at baseline and after 6 months
Placebo Comparator: Placebo Drug: 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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480661

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
ZNA Middelheim
Antwerp, Belgium, 2020
Sponsors and Collaborators
FluidDA nv
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
Principal Investigator: Lieven Bedert, MD ZNA Middelheim
  More Information

No publications provided

Responsible Party: FluidDA nv
ClinicalTrials.gov Identifier: NCT01480661     History of Changes
Other Study ID Numbers: FLUI-2011-77, 2011-004271-36
Study First Received: November 21, 2011
Last Updated: September 18, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by FluidDA nv:
Pulmonary Disease, Chronic Obstructive
Computed Tomography scan
Functional Respiratory Imaging
Roflumilast
Health Related Quality of Life

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014