Sixteen children completed a randomized placebo-controlled double-blind study comparing the efficacy of pre-treatment with (1) 20 mg sodium cromoglycate (SCG) powder delivered by Spinhaler, (2) 2 mg SCG delivered by pressurized aerosol and (3) placebo. The drug was administered 15 min before the 6 min of treadmill-running performed at the same time of day on 3 consecutive days in a climate chamber with a temperature of 23°C and a relative humidity of 40%,. All the patients, none of whom were taking systemic steroids, had shown a post-exercise fall in peak expiratory flow (PEF) of more than 15% from baseline when tested one day prior to the study. On the day with no pre-treatment the average post-exercise fall in PEF was 46% (±4) (mean ± s.e.mean). After pre-treatment with SCG powder the average fall in PEF was 21%, (±3), after pre-treatment with SCG aerosol the fall was 22% (±3) and after placebo a post-exercise fall of 31% (±5) was seen. Both forms of SCG were significantly better than pre-treatment with placebo. Comparing no pre-treatment with pre-treatment with placebo revealed a statistically significant difference (P < 0.001) indicating a placebo effect. It is concluded that this study design has a marked placebo effect. Both pre-treatment with 2 mg SCG delivered by pressurized aerosol and 20 mg delivered by Spinhaler is superior to placebo in conferring protection against exercise-induced asthma (EIA). No bronchodilating effect was seen in the first 15 min after administration of the drug.
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