| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described |
| Participants |
N = 142 (randomised)
N = 134 (completed) WITHDRAWAL/DROPOUT: 8 due to protocol violations
AGE: 4 months‐ 4 years (mean 22,3 months)
SEVERITY: wheezing for at least 8 weeks; wheezing or coughing at entry into study; presence of allergy and nasal discharge (optional); exclusion of patients with any serious or other chronic disorder |
| Interventions |
DOSE: 0,5 mg twice daily
RUN‐IN: 2 weeks
TREATMENT: 12 weeks
ADDITIONAL MEDICATION: "bronchodilator use" |
| Outcomes |
asthmatic attacks, wheeze on auscultation, bronchodilator use, nasal symptoms, side effects |
| 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 |
