Methods |
RCT, crossover, double blind study
2 ‐week run‐in period, followed by three 4‐week study periods , each separated by a 1‐week washout. The following treatments were given during the double‐blind periods: budesonide 50 mcg, budesonide 100 mcg and placebo.
2 drop‐outs due to asthma exacerbation and toe fracture
Concomitant treatment: short acting beta agonist as needed
Exercise test: treadmill to achieve heart rate of > 180/min |
Participants |
N=27. 20m, 7 f. Age 6‐14 years, mean age 10.6. All had FEV1 > 70% predicted and post exercise reduction in FEV1 of at least 15%. |
Interventions |
In random order: Budesonide autohaler 50 mcg or 100 mcg or placebo for 4 weeks. |
Outcomes |
Maximal percentage fall in FEV1 after exercise was measured. The percentage fall from pre‐exercise at each time point was also calculated. The mean percentage fall in FEV1 was plotted against time for each treatment. The area under the curve (AUC) for the percentage fall in FEV1 from exercise over the 20 min period was calculated using trapezoidal rule. In addition, exhaled nitric oxide measurements were made from the start of the run‐in and at the end of study period. Adverse events were recorded. |
Notes |
Jadad score 3 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
Information not available |