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. 2008 Apr 23;2008(2):CD007031. doi: 10.1002/14651858.CD007031

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.
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