Skip to main content
. 2013 Oct 2;2013(10):CD003564. doi: 10.1002/14651858.CD003564.pub3

DeBenedictis 1996 Salm 25.

Methods Study design: Randomized, double blind, cross over
Study location: Italy
Wash‐out: 2‐10 days
Exercise challenge: Treadmill for 6 min at 85% of max HR
Criteria for EIB diagnosis: FEV1 fall >15% after exercise challenge
Participants Number of subjects: 12
% of males: 83%
Age range: 7‐14 years
Ethnicity: Not reported
Withdrawal or drop out: 0
Interventions Drug administration: Single dose
Time of exercise challenge after drug administration: 1 hour, 12 hours
Intervention: Salmeterol 25 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: Side effects; Number of patients with a max FEV1 % fall <10%
Notes  
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