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 |