Conditions: Asthma
Keywords: Inhalation, Pharmacodynamic, Patients,
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 95
Healthy volunteers: no

Brief summary:
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

Detailed description:
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.

Arms:
arm 1: Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation arm 2: Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation arm 3: Placebo powder for inhalation arm 4: Placebo powder for inhalation

Interventions: intervention 1: Terbutaline sulphate intervention 2: Terbutaline sulphate intervention 3: Placebo for terbutaline sulphate intervention 4: Placebo for terbutaline sulphate
Intervention descriptions: intervention 1: Bricanyl Turbuhaler M2 intervention 2: Bricanyl Turbuhaler M3 intervention 3: Placebo Turbuhaler M2 intervention 4: Placebo Turbuhaler M3

Protocol document: