| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described |
| Participants |
N = 120 (randomised)
N = 107 (completed)
WITHDRAWAL/DROPOUT: 4 in Ketotifen group (development of hepatitis B: 1, bronchiectasis: 1, not taking > 75% of trial drug: 2), 9 in placebo group (development of hepatitis B: 1, pulmonary tuberculosis: 1, not taking > 75% of trial drug: 3, dropout: 4)
AGE: 5‐15 years
SEVERITY: reversible bronchospasm; improvement in PEFR > 20% after inhalation of salbutamol; duration of asthma more than 1 year; no history of taking steroids, ketotifen, or sodium cromoglycate in the previous 3 months |
| Interventions |
DOSE: 1mg twice daily
RUN‐IN: 4 weeks
TREATMENT: 20 weeks
ADDITIONAL MEDICATION: salbutamol, theophylline, inhaled steroids, oral prednisolone |
| Outcomes |
symptom score, symptom free days, lung function parameters, additional medication, 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 |
