Status:
UNKNOWN
Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
COPD
Emphysema
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Inuvair® is a novel fixed combination product used in the treatment of asthma and under clinical development for the treatment of COPD. Thanks to the extrafine particle size, it is able to target the ...
Eligibility Criteria
Inclusion
- clinical diagnosis COPD according to last updated GOLD guidelines (post- bronchodilator FEV/FVC below 0,70, FEV1 \<80% predicted)
- ex-smokers (ie 1 year from the last cigarette) with at least 10 pack years.
- GOLD stage II and III (FEV1 \> 30% predicted)
- by preference naïve to inhaled corticosteroids; in those taking inhaled corticosteroids this medication will be stopped 1 month prior to enrollment in the study
- Patients must have proven small airways dysfunction on routine spirometry as reflected by a drop in FEF25-75 and FEF75 of at least 50%. Moreover, patients must have proven small airways dysfunction on MBW as reflected by Sacin \>0,120 that is considered abnormal.
Exclusion
- Current smoking
- Active COPD exacerbation
- gold stage I and IV
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01466712
Start Date
November 1 2011
End Date
December 1 2014
Last Update
July 30 2013
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Flanders, Belgium, 3000