Methods |
Design: randomized, double‐blind, placebo‐controlled crossover study. 3 test days at same time on separate days, completed within 10 days. Method of randomization not clearly described. Withdrawals: not mentioned. |
Participants |
Italy. Recruitment: pediatric asthma clinic. N=8 children, 5 m, 3 f. Age: 7‐11 (mean 8.7) Inclusion: asthmatic (ATS criteria), reproducible EIA (fall in FEV1 > 15%), baseline FEV1 must be > 70% predicted normal and vary < 10% from previous study day. Excluded: patients with URI in past 4 wks, no patients on oral steroids. Witheld: sustained‐release theophylline x 24 hr. other drugs x 12 hr. |
Interventions |
Randomized order to: NCS 4 mg or SCG 10 mg or placebo via MDI with Aerochamber spacer 20 min. pre‐exercise test. Inhalation technique monitored. Exercise test: inclined treadmill, 6 min., pulse=85% of max predicted for age. |
Outcomes |
Used turbine spirometer & Knudson's predicted values. Measured: FEV1 pre Tx, pre‐exercise then 3, 5, 10, 15, 30 min. post exercise. Calculated: Max % fall in FEV1, % protection, complete protection (% decr. FEV1<10%), clinical protection. Side effects: not mentioned. |
Notes |
Jadad score = 3
Author contacted and confirmed data extraction. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
Information not available |