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. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

Jonasson 1998.

Methods Setting: Norway, paediatric outpatient clinic 
 Length of intervention period: 12 weeks 
 Randomisation: yes, computer‐generated randomisation schedule 
 Allocation concealment: yes 
 Design: parallel 
 Masking: double blind 
 Excluded: stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score=4
Participants 163 children: 107M 56F 
 Age range: 7‐16 years 
 Inclusion criteria: 
 Children with a diagnosis of asthma (based on criteria of an International Consensus Report 1992) 
 3 previous obstructive episodes or 1 previous obstructive episodes with atopy 
 Exclusion criteria: 
 Use of inhaled corticosteroids within last 2 months 
 Use of cromoglycate or nedocromil within last 4 weeks 
 Asthma exacerbation requiring emergency room visit or hospital admission within last 4 weeks 
 Lower respiratory tract infection within last weeks
Interventions BUD: 
 1. 100 mcg 1xdaily morning (100 mcg/d) 
 2. 200 mcg 1xdaily morning (200 mcg/d) 
 3. 100 mcg 2xdaily (200 mcg/d)
Placebo: 2xdaily
Delivery device: Turbuhaler DPI
Outcomes Maximal percentage fall in FEV1 post exercise test 
 FEV1 
 FEF 25, 50, 75 
 Morning PEFR 
 Methacholine BHR (PD20 FEV1) 
 Daytime asthma symptom score 
 Night‐time asthma symptom score 
 Daytime beta2 agonist use 
 Night‐time beta2 agonist use
Notes Reply from author confirming use of allocation concealment and provided standard deviation values for mean fall is FEV1 post exercise challenge.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate