NCT01480661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

November 21, 2011

Last Update Submit

September 18, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic ObstructiveComputed Tomography scanFunctional Respiratory ImagingRoflumilastHealth Related Quality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)

    At baseline and after 6 months of treatment

  • Health related quality of life

    At baseline and after 6 months of treatment

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR
Drug: RoflumilastRadiation: Functional Respiratory Imaging

Placebo

PLACEBO COMPARATOR
Drug: Placebo of RoflumilastRadiation: Functional Respiratory Imaging

Interventions

RoflumilastDRUG

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

Also known as: Daxas®
Roflumilast
Placebo of RoflumilastDRUG

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

Placebo
Functional Respiratory ImagingRADIATION

CT scan of thorax, at baseline and after 6 months

PlaceboRoflumilast

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ZNA Middelheim

Antwerp, Antwerp, 2020, Belgium

Location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wilfried De Backer, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Lieven Bedert, MD

    ZNA Middelheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 29, 2011

Study Start

December 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

BE(2)