Randomised, double-blind, double-dummy, cross-over trial comparing a novel DPI with formoterol versus Oxis Turbohaler 12 µg in patients with stable persistent asthma

INTERVENTION: Product Name: oxis turbohaler Pharmaceutical Form: Inhalation powder CAS Number: 43229‐80‐7 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 12‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Name: Formoterol DPI Pharmaceutical Form: Inhalation powder CAS Number: 43229‐80‐7 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 12‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Adult patients with stable persistent asthma ; MedDRA version: 9.0 Level: LLT Classification code 10049106 PRIMARY OUTCOME: Main Objective: Comparison of lung function after Formoterol DPI or Oxis Turbohaler measured as FEV1 determined as change from start to end of treatment Primary end point(s): Change from start of treatment period of 2h‐AUC of FEV1, evaluated at time points of 0, 5, 10, 15, 30, 60, 90 and 120 min after treatment Secondary Objective: additional lung function variables (FVC, FEV1/FVC, FEF25%, FEF25‐75%) between start and end of treatment, peak expiratory flow rate during treatment, sum score of asthma symptoms cough, wheezing and dyspnoea, as well as the number of nocturnal awakenings during treatment, use of rescue medication during treatment INCLUSION CRITERIA: All of the following criteria have to be met for inclusion of a subject in the study: ‐ men or women aged between 18 and 65 years ‐ written informed consent of patient ‐ current diagnosis of persistent asthma according to generally acknowledged criteria ‐ stable daily regimen of anti‐inflammatory therapy (such as inhaled corticosteroids) upon at least 4 weeks ‐ a forced expiratory volume in one second (FEV1) between 40 and 90% of the predicted normal value ‐ documented FEV1‐reversibility of at least 12% ‐ capable of understanding the directions for device usage Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range