Baran 1987.
Methods | Setting: Belgium, residential centre for asthmatic children Length of intervention: 3 weeks Design: crossover, no washout Randomisation: yes, method not stated Allocation concealment: unclear Masking: double blind Excluded: not stated Withdrawals: stated (none) Baseline characteristics: no tabulated demographic data Jadad score: 3 | |
Participants | 21 children: 15M 6F Age range: 4‐14 Inclusion criteria: Children suffering from chronic asthma and using inhaled corticosteroids to control their disease No other criteria given Exclusion criteria: None stated | |
Interventions | BDP: 50 mcg 2puffs 2xdaily (200 mcg/d) via MDI BUD: 50 mcg 2puffs 2xdaily (200 mcg/d) via Inhalet spacer |
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Outcomes | FEV1 FVC Morning PEFR Evening PEFR Daytime breathlessness score Night‐time breathlessness score Daily cough score Sleeping difficulties score 8 am plasma cortisol Incidence of oropharyngeal Candidiasis Both active treatment arms demonstrated significant improvements compared to non‐randomised placebo arm for morning PEFR, evening PEFR and symptom scores. | |
Notes | No reply from author to clarify details of randomisation method Not stated if carryover effects were tested for. Significant improvements in morning PEFR, evening PEFR and symptoms compared to non‐randomised placebo treatment period at end of study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |