Richter 2002 Form 12.
Methods | Study design: Randomized, double blind, cross over Study location: Germany Wash‐out: ≥2 days Exercise challenge: Cycle‐ergometer for 6 min up to 85% of max HR Criteria for EIB diagnosis: Positive history; Positive methacholine test (PC20 <8mg/ml); Positive exercise challenge |
|
Participants | Number of subjects: 25 % of males: 66% Age range: 19‐36 years Ethnicity: Not reported Withdrawal or drop out: 1 |
|
Interventions | Drug administration: Single dose Time of exercise challenge after drug administration: 5 min, 30 min, 1 hour Intervention: Terbutaline 500 mcg; Formoterol 12 mcg; Salmeterol 50 mcg Control: Placebo Other drug arms: None Concomitant inhaled corticosteroid (ICS) treatment: Allowed |
|
Outcomes | Primary available: Max FEV1 % fall; % protection; FEV1 % fall AUC Secondary available: None |
|
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 |