Ferrari 2000 Form 12.
Methods | Study design: Randomized, double blind, cross over Study location: Italy Wash‐out: ≧2 days Exercise challenge: Cycle‐ergometer for 7 min at 85% of max HR Criteria for EIB diagnosis: FEV1 fall >15% after exercise challenge |
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Participants | Number of subjects: 14 % of males: 92% Age range: 12‐28 years Ethnicity: Not reported Withdrawal or drop out: 0 |
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Interventions | Drug administration: Single dose Time of exercise challenge after drug administration: 15 min, 4 hours Intervention: Formoterol 12 mcg Control: Placebo Other drug arms: None Concomitant inhaled corticosteroid (ICS) treatment: Allowed |
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Outcomes | Primary available: Max FEV1 % fall; % protection; Secondary available: Side effects; Number of patients with a max FEV1 % fall <10% |
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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) | High risk | Statistical analysis and manuscript writing made by drug industry staff |
Other bias | Unclear risk | Insufficient information |