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 |
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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 |