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. 2005 Jan 24;2005(1):CD002738. doi: 10.1002/14651858.CD002738.pub2

Simons 1997.

Methods Setting: multicentre study Canada, hospital outpatient clinics 
 Length of intervention period: 12 months 
 Randomisation: yes, computer generated sequence 
 Allocation concealment: yes (off site body generated list, with coded schedules) 
 Design: parallel group 
 Masking: double blind 
 Excluded: stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score: 4
Participants 241 children: 140M 101F 
 Age range: 6 to 14 years 
 Inclusion criteria: 
 Children with clinically stable asthma (not otherwise defined) 
 No more than 1 month of treatment with corticosteroids for asthma in past 
 No inhaled or oral corticosteroid treatment within last 3 months 
 FEV1 > 70 (% predicted) 
 10% or greater increase in FEV1 after inhaled beta2 agonist 
 Methacholine BHR (PC20 FEV1 < 8mg/ml) 
 Exclusion criteria: 
 Emergency dept attendance or hospital admission due to asthma exacerbation within last 3 months 
 History of life‐threatening asthma 
 History of adverse reaction to study medications
Interventions BDP: 200 mcg 2x daily (400 mcg/d)
Placebo: 2xdaily
Delivery device: Diskhaler DPI
Outcomes Methacholine BHR (PC20 FEV1) 
 FEV1 (% predicted) 
 FEV1 
 FVC 
 FEF 25, FEF 50, FEF 75, FEF25‐75 
 Morning PEFR 
 Evening PEFR 
 Clinic PEFR 
 Rescue beta2 agonist not required (% of children) 
 Waking at night (% of nights) 
 No school missed because of asthma (% of children) 
 Waking at night (% of nights) 
 Activities affected by asthma (% of days) 
 Height assessment 
 Blood eosinophil count 
 Withdrawal due to asthma exacerbation (number of patients)
Notes Reply from author clarifying method of random order generation and use of allocation concealment. 
 Exacerbation of asthma defined as the presence of symptoms despite study medication and the use of albuterol as rescue medication. 
 If an exacerbation occurred, children were treated with oral prednisolone 1mg/kg for 5 to 7 days. 
 If symptoms still not controlled children were withdrawn. 
 Also withdrawn if : 
 More than 1 course prednisolone required in month or 4 in year or: 
 Hospitalization for asthma required 
 Non‐parametric tests used to compare symptom outcomes 
 Salmeterol treatment arm: results not included
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate