Article type
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Abstract
Introduction/Objective: To assess the effectiveness and safety of using a single dose of nedocromil sodium (NCS) to prevent exercise-induced bronchoconstriction (EIB).
Methods: Computerised searches were conducted using the Cochrane Airways Review Group RCT register, Current Contents, and the CC Controlled Trials Register. Bibliographic searches, communication with the drug manufacturer and author contact were used to identify published, unpublished, or "in progress" trials. No language restrictions were applied. Randomised, double-blind, controlled trials that compared a single dose of NCS to a placebo in prophylactic treatment of EIB were eligible. Studies were included if: the participants had confirmed EIB, were subjected to an exercise challenge sufficient to produce EIB, and measures of lung function were reported as changes in forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR). The main outcomes assessed were the maximum percent reductions in FEV1 (max % FEV1) and PEFR (max % PEFR) after exercise, compared to pre-exercise baselines, the effect of NCS on the FEV1 over 30 minutes post exercise, and adverse effects caused by NCS. Data extraction and quality assessments were conducted independently by two reviewers using standard forms and validated assessment criteria. Results from similar studies were pooled and reported as the weighted mean difference (WMD) between treatment and placebo effects using the random effects model.
Results: From 51 potentially relevant trials, 20, representing data on 280 participants met the inclusion criteria. All studies employed crossover design. NCS had a significant effect on inhibiting EIB in both adults and children. The WMD for the mean maximum % fall index for FEV1 was 15.6% (95% Cl: 13.1%, 18.1%), a protective effect of 51% (95% Cl: 46%, 55%) over placebo. The time to recovery post-exercise was less than 10 minutes using NCS vs 30 minutes using placebo. Significant differences in the inhibitory effect of NCS were demonstrated in subgroup analyses based on severity of EIB (mild EIB: < 30% fall; moderate-severe EIB: >= 30% fall). The WMD for mean maximum % fall FEV1 in mild EIB was 12.8% (95% Cl: 10.0%, 15.7%) compared to 21.4% (95% Cl: 17.2%, 25.5%) in more severe EIB. There were no important differences between groups in the reported adverse effects.
Discussion: The prophylactic use of single dose NCS in EIB was effective in inhibiting post-exercise bronchoconstriction and in shortening the duration of this response. Further research in EIB is required to compare alternative drugs to NCS using additional outcome measures.
Methods: Computerised searches were conducted using the Cochrane Airways Review Group RCT register, Current Contents, and the CC Controlled Trials Register. Bibliographic searches, communication with the drug manufacturer and author contact were used to identify published, unpublished, or "in progress" trials. No language restrictions were applied. Randomised, double-blind, controlled trials that compared a single dose of NCS to a placebo in prophylactic treatment of EIB were eligible. Studies were included if: the participants had confirmed EIB, were subjected to an exercise challenge sufficient to produce EIB, and measures of lung function were reported as changes in forced expiratory volume in one second (FEV1) or peak expiratory flow rate (PEFR). The main outcomes assessed were the maximum percent reductions in FEV1 (max % FEV1) and PEFR (max % PEFR) after exercise, compared to pre-exercise baselines, the effect of NCS on the FEV1 over 30 minutes post exercise, and adverse effects caused by NCS. Data extraction and quality assessments were conducted independently by two reviewers using standard forms and validated assessment criteria. Results from similar studies were pooled and reported as the weighted mean difference (WMD) between treatment and placebo effects using the random effects model.
Results: From 51 potentially relevant trials, 20, representing data on 280 participants met the inclusion criteria. All studies employed crossover design. NCS had a significant effect on inhibiting EIB in both adults and children. The WMD for the mean maximum % fall index for FEV1 was 15.6% (95% Cl: 13.1%, 18.1%), a protective effect of 51% (95% Cl: 46%, 55%) over placebo. The time to recovery post-exercise was less than 10 minutes using NCS vs 30 minutes using placebo. Significant differences in the inhibitory effect of NCS were demonstrated in subgroup analyses based on severity of EIB (mild EIB: < 30% fall; moderate-severe EIB: >= 30% fall). The WMD for mean maximum % fall FEV1 in mild EIB was 12.8% (95% Cl: 10.0%, 15.7%) compared to 21.4% (95% Cl: 17.2%, 25.5%) in more severe EIB. There were no important differences between groups in the reported adverse effects.
Discussion: The prophylactic use of single dose NCS in EIB was effective in inhibiting post-exercise bronchoconstriction and in shortening the duration of this response. Further research in EIB is required to compare alternative drugs to NCS using additional outcome measures.