Zietkowski 2006.
Methods | STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: One centre in Poland. DURATION OF STUDY: 12 weeks (1‐4 week run in on prn SABA) CONCEALMENT OF ALLOCATION: Unclear COCHRANE QUALITY SCORE: B DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Not reported METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Double‐dummy DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not reported JADAD SCORE (5‐1): 3 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): Assumed available case. COMPLIANCE: Not reported CONFOUNDERS: Baseline values comparable. | |
Participants | N SCREENED: Not clear N RANDOMISED: 35 (CIC80: 12; CIC160: 12; FP200: 11) N COMPLETED: 35 M = 19; F = 16 MEAN AGE: 45 years BASELINE DETAILS: Duration of symptoms: 15 years; allergic rhinitis: 23/35 participants INCLUSION CRITERIA: Mild allergic asthma (according to GINA guidelines); free from exacerbations in previous four weeks; non‐smokers; treatment with FP equivalent 250mcg/d. EXCLUSION: Not reported. | |
Interventions | 1. Ciclesonide 100 mcg OD
2. Ciclesonide 200 mcg OD
3. Fluticasone 100 mcg BID DELIVERY: unclear TREATMENT PERIOD: 12 weeks RESCUE: Salbutamol CO‐INTERVENTIONS PERMITTED: Not reported. CO‐INTERVENTIONS: Not listed. % on ICS pre‐baseline: 100. |
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Outcomes | FEV1 L; FEV1 predicted; symptoms; rescue medication use | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |
AQLQ: Asthma quality of life questionnaire; ATS: American Thoracic Society; BDP: beclomethasone dipropionate; BID: twice daily; BUD: budesonide; CFC‐MDI: Chlorofluorocarbon metered dose inhaler; CIC: Ciclesonide; COPD: Chronic obstructive pulmonary disease; DPI: Dry powder inhaler device; FEV1: forced expiratory volume in one second; FP: fluticasone propionate; FVC: forced vital capacity; GINA: Global initiative for asthma; HFA‐MDI: Hydro‐fluoroalkane metered dose inhaler; HPA: hypothalamic‐pituitary‐adrenal; ICS: inhaled corticosteroids; ITT: intention‐to‐treat; LABA: Long‐acting beta2‐agonist; MDI: metered dose inhaler; OCS: oral corticosteroids; OD: once daily; PEF: peak expiratory flow; PP: per‐protocol; RTI: respiratory tract‐infection; SABA: short‐acting beta‐agonist; SCG: sodium cromoglycate