Philip 2007 Salm 50.
Methods | Study design: Randomized, double blind, cross over Study location: South America Wash‐out: 3‐7 days Exercise challenge: Treadmill for 6 min up to 80‐90% of max HR Criteria for EIB diagnosis: FEV1 fall >20% and <40% after exercise challenge |
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Participants | Number of subjects:47 % of males: 49% Age range: 15‐45 years Ethnicity: 55% Caucasian; 45% Others Withdrawal or drop out: 1 |
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Interventions | Drug administration: Single dose Time of exercise challenge after drug administration: 2 hours, 8.30 hours, 24 hours Intervention: Salmeterol 50 mcg Control: Placebo Other drug arms: Oral Montelukast 10 mg Concomitant inhaled corticosteroid (ICS) treatment: Allowed |
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Outcomes | Primary available: Max FEV1 % fall; % protection Secondary available: Side effects |
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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 |