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DOI: 10.1055/s-0030-1251444
Synergistic effect of disodium cromoglycate and reproterol in preventing exercise-induced asthma (EIA) in adults
Objective: To compare the protective effect of disodium cromoglycate (D), reproterol (R), their fixed drug combination (A) (Allergospasmin® N/Aarane® N), and placebo (P) in adults with EIA.
Methods: Double-blind, randomised, placebo-controlled, multi-centre, 4-fold crossover study. At each visit patients underwent a standardised treadmill test to provoke EIA. Patients with stable asthma, baseline FEV1≥70% predicted and twice proven EIA (i.e. max. decrease in FEV1 by ≥15% compared to baseline) were randomised to inhale either a dose of A, D, R, or P 20 minutes before exercise challenge. FEV1 was measured before inhalation, prior to exercise, and at 5 to 60 minutes after exercise. A stepwise hierarchical statistical test was applied based on crossover ANOVA to prove superiority of A vs. R, A vs. D, A vs. P, R vs. P, and D vs. P.
Results: 61 patients (mean age 31±12 years, 32 males) completed the study. Statistical significance was obtained for all pairwise comparisons for both the maximal percentage decrease in FEV1 after exercise and the baseline adjusted area under the FEV1 curve.
Confirmatory test results (crossover ANOVA) |
|||||
Comparison |
Difference in % FEV1-fall |
95%-confidence interval |
p-value |
||
A – R |
-2.24 |
-4.10 |
to |
-0.38 |
0.0193 |
A – D |
-13.03 |
-16.15 |
to |
-9.91 |
<0.0001 |
A – P |
-19.13 |
-23.06 |
to |
-15.20 |
<0.0001 |
R – P |
-17.04 |
-21.39 |
to |
-12.70 |
<0.0001 |
D – P |
-6.10 |
-9.23 |
to |
-2.97 |
0.0002 |
Conclusion: This study confirmed a synergistic effect of disodium cromoglycate and reproterol in their fixed drug combination in preventing exercise-induced asthma in adults.