Status:
COMPLETED
Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients
Lead Sponsor:
FLUIDDA nv
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01480661
Start Date
December 1 2011
End Date
April 1 2013
Last Update
September 19 2013
Active Locations (2)
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1
ZNA Middelheim
Antwerp, Antwerp, Belgium, 2020
2
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650