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. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

Boner 1995.

Methods Setting: Italy, hospital outpatient clinic 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Design: parallel 
 Intervention period: 3 months at low altitude, 2 weeks at high altitude 
 Masking: double blind 
 Excluded: stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score=3
Participants 20 children completed the study: 13M 7F 
 Age range 6‐14 years 
 Inclusion criteria: 
 Clinical history of asthma 
 Positive skin allergen test to house dust mite or grass pollen 
 FEV1 (% predicted) > 75 
 Methacholine BHR (PC20 FEV1) < 10mg/ml 
 Exclusion criteria: 
 Respiratory infection during the previous 4 weeks 
 Significant disease other than asthma or related allergic diseases 
 Use of oral, inhaled or injectable steroids during previous 3 months
Interventions BUD: 200 mcg 1pf 2xdaily (400mcg/d)
Placebo: 1 pf 2xdaily
Delivery device: Turbuhaler DPI
Outcomes FEV1 (% predicted) 
 FVC (% predicted) 
 FEF 25‐75 (% predicted) 
 Change in morning PEFR (% predicted) compared to baseline 
 Change in evening PEFR (% predicted) compared to baseline 
 Methacholine BHR (PC20 FEV1) 
 Daily asthma symptom score
Notes Reply form authors who provided numerical data for clinic spirometry, methacholine challenge and diary card PEFR. Authors did not clarify whether allocation concealment was employed in randomisation procedure. 
 Study comprised two parts: an initial period at high altitude avoiding allergen exposure where patients were treated for 2 weeks and a second period at low altitude when patients were treated for a further 3 months. 
 The data included in the meta‐analysis is for the second period at low altitude.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear