| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described |
| Participants |
N = 41 (randomised)
N = 36 (completed) WITHDRAWAL/DROPOUT: 5 (deterioration: 3, non‐compliance: 2)
AGE: 4‐14 years (mean 9,8 years)
SEVERITY: allergic asthma with a minimum of 2 asthma attacks per month |
| Interventions |
DOSE: 1 mg twice daily
RUN‐IN: 0 weeks
TREATMENT: 16 weeks
ADDITIONAL MEDICATION: continuous antiasthmatic treatment stopped at first visit, thereafter, beta‐2 receptor stimulants, steroids allowed if needed |
| Outcomes |
clinical assessment (parents and physicians), PEFR, bronchodilator consumption |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; no other information available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Unclear risk |
Information not available |
