Simons 1997.
Methods | Study design: Randomized, double blind, cross over Study location: Canada Wash‐out: 14 days Exercise challenge: Treadmill for 8 min up to 90% of max HR or 180 bpm Criteria for EIB diagnosis: Asthma according to ATS; Positive exercise challenge |
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Participants | Number of subjects: 16 % of males: 41% Age range: 12‐16 years Ethnicity: Not reported Withdrawal or drop out: 2 |
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Interventions | Drug administration: Chronic administration (28 weeks) Time of exercise challenge after drug administration: 1 hour, 9 hours Intervention: Salmeterol 50 mcg Control: Placebo Other drug arms: None Concomitant inhaled corticosteroid (ICS) treatment: Allowed |
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Outcomes | Primary available: Max FEV1 % fall; % protection; FEV1 % fall AUC Secondary available: None |
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Notes | Industry funded study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization described explicitly |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information |
Selective reporting (reporting bias) | Unclear risk | Insufficient information |
Other bias | Unclear risk | Insufficient information |