Bronski 1999 Salm Disk.
Methods | Study design: Randomized, double blind, cross over Study location: United States Wash‐out: 2‐14 days Exercise challenge: Treadmill for 6 min at 85% of max HR Criteria for EIB diagnosis: FEV1 fall >20% after exercise challenge |
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Participants | Number of subjects: 24 % of males: 58% Age range: 4‐11 years Ethnicity: 91% Caucasians, 9% Blacks Withdrawal or drop out: 0 |
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Interventions | Drug administration: Single dose Time of exercise challenge after drug administration: 30 min, 5:30 hours, 11:30 hours Intervention: Salmeterol 50 mcg Diskus, Salmeterol 50 mcg Diskhaler Control: Placebo Other drug arms: None Concomitant inhaled corticosteroid (ICS) treatment: Not allowed |
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Outcomes | Primary available: max FEV1 % fall, % protection, FEV1 fall AUC Secondary available: Side effects, Number of patients with a max FEV1 % fall <15%, <20% |
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Notes | Industry funded study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information |
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 |