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Randomized Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function in COPD Patients.
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 whole bronchial tree, including the small airways and hence, is expected to act in these airways and it may thus be beneficial in COPD in that sense. In COPD, its action on the small airways is not directly demonstrated thus far. By way of contrast, dear evidence is present that treatment with bronchodilators alone does not beneficially alter small airway function. The study hypothesis states that the effects of inhaled corticosteroids or ICS/LABA combinations on small airway is present and can be objectivated.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University Hospitals Leuven
Leuven, Flanders, Belgium
Start Date
November 1, 2011
Primary Completion Date
December 1, 2014
Completion Date
December 1, 2014
Last Updated
July 30, 2013
20
ESTIMATED participants
Tiotropium + formoterol/beclometasone
DRUG
tiotropium + placebo
DRUG
Lead Sponsor
KU Leuven
Collaborators
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
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