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 |
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| 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 |
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| 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 |