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. 2000 Apr 24;2000(2):CD003271. doi: 10.1002/14651858.CD003271

Jonasson 1998.

Methods Setting: Norway, paediatric outpatient clinic 
 Randomisation: yes, computer generated sequence 
 Allocation concealment: yes 
 Design: parallel group 
 Length of intervention period: 12 weeks 
 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 4 weeks
Baseline asthma control 
 Symptom frequency: not stated 
 FEV1 (% predicted): mean > 100
Interventions 1. BUD 100 mcg 1xdaily morning (100 mcg/day) via Turbuhaler DPI
2. 200 mcg 1xdaily (200 mcg/day) morning via Turbuhaler DPI
3. 100 mcg 2xdaily via Turbuhaler DPI (200 mcg/d)
Each group received appropriate number of actuations of placebo to maintain blinding
4. Placebo: 2xdaily via Turbuhaler DPI
Outcomes FEV1 
 Maximal percentage fall in FEV1 post exercise test 
 Morning PEFR 
 FEF 25 
 FEF 50 
 FEF 75 
 Methacholine bronchial responsiveness (PD20 FEV1) 
 Daytime asthma symptom score 
 Night‐time asthma symptom score 
 Daytime use of beta2 agonists 
 Night‐time use of beta2 agonist 
 Withdrawal due to asthma exacerbation
Notes Reply from author clarifying method of random order generation, use of allocation concealment and provided numerical data for exercise challenge. 
 Exercise test involved a six minute run on a motor driven treadmill with speed adjusted to achive a submaximal exercise load and a steady state heart rate of 170‐180 bpm.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate