A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma
The study will include female and male patients, between 18 and 65 years old, with stable, mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order to have 49 completed. The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20 (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure Adverse Events/Serious. Study period Q1 2015 - Q1 2016.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
95
Bricanyl Turbuhaler M2
Bricanyl Turbuhaler M3
Placebo Turbuhaler M2
Research Site
Hamilton, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Groningen, Netherlands
Research Site
Lund, Sweden
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
Time frame: 4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
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Placebo Turbuhaler M3