BY9010/M1‐205.
Methods | Randomised controlled trial, double‐blind, study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks) |
Participants | Children aged 4 to 15 years Main inclusion criteria: history of persistent bronchial asthma for at least 6 months, forced expiratory volume in one second (FEV1) 50‐90% of predicted Main exclusion criteria: concomitant severe diseases or diseases which are contraindications for the use of inhaled corticosteroids; chronic obstructive pulmonary disease (chronic bronchitis or emphysema), other relevant lung diseases causing alternating impairment in lung function, or a combination; respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study; history of life‐threatening asthma; premature birth; current smoking; smoking history with either ≥ 10 pack‐years; pregnancy; intention to become pregnant during the course of the study; breast feeding; lack of safe contraception |
Interventions | Ciclesonide 200 μg/day Fluticasone propionate 200 μg/day |
Outcomes | Primary outcome measures: FEV1 absolute values Secondary outcome measures: FEV1 as % of predicted, peak expiratory flow (PEF) from spirometry, diary‐based morning and evening PEF, diary‐based symptom score, diary‐based salbutamol metered dose inhaler (MDI) use, diurnal PEF fluctuation, drop‐out rate due to asthma exacerbations, time until asthma exacerbation, number of symptom‐free and rescue medication‐free days, number of days with asthma control, physical examination, vital signs, laboratory work‐up, adverse events |
Notes |