Trial | NCT01480661  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    roflumilast ...

  • Study Participants

    41
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 Started
Dec 31
2011
Primary Completion
Apr 30
2013
Study Completion
Apr 30
2013
Last Update
Sep 19
2013
Estimate

Drug Roflumilast

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

  • Other names: Daxas®

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

Roflumilast Active Comparator

Placebo Placebo Comparator

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).
No Results Posted