Stelmach 2008.
Methods | RCT, double‐blind, parallel study. Regular medications stopped for 4 weeks. Concomitant treatment: bronchodilators allowed ( except < 6 hours of exercise test). Exercise test: treadmill to achieve heart rate of 95% maximum predicted for age. |
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Participants | N= 39. Age 6‐18 years. Stable atopic asthmatics who were on inhaled budesonide ( average 400 mcg/day) and montelukast or long‐acting bronchodilator. Inlcusion criteria: Clinical diagnosis of asthma of at least 6 months, resting FEV1 or at least 70% or more and reduction in FEV1 of 20% or more after exercise. Exclusion criteria: recent upper respiratory tract infection (including sinusitis), previous intubation, or asthma hospitalization during 3 months before pre‐study visit. Patients with significant co‐morbidities and patients using beta‐blocker, oral corticosteroids or immunotherapy were also excluded. |
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Interventions | In random order: Budesonide turbuhaler 100mcg bid or placebo inhalers for 4 weeks. Other treatment arms studied were: budesonide + formoterol ( 4.5 mcg bid) inhaler; Budesonide + montelukast ( 5 mg/day or 10mg /day depending on age ), montelukast ( 5mg/day or 10 mg/day depending on age ) |
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Outcomes | Maximal percentage fall in FEV1 after exercise was measured. The area under the curve (AUC) for the percentage fall in FEV1 from exercise over the 20 min period was calculated. | |
Notes | Jadad score 4 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | information not available |