Garrett 1998.
Study characteristics | ||
Methods |
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Participants |
Population 28 participants were randomised; 18 pairs of exacerbations in both cross‐over periods contributed to the analysis. Participants were 6 to 14 years old; mean age was 8.2 years; 67% were male; smoking status not reported as paediatric trial (likely all non‐smokers). Inclusion criteria Age 6 to 14 years; currently taking inhaled corticosteroid prophylaxis (not exceeding 800 μg/d) Exclusion criteria Taking oral corticosteroids, sodium cromoglycate, or LABA; any previous intensive care admission, recent inpatient care for asthma, or any change in dose of inhaled corticosteroids in the past 2 months; any concurrent illness Baseline asthma severity See Table 2. |
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Interventions |
Run‐in period 2‐week run‐in period during which participants were required to use beclomethasone via MDI and spacer and a salbutamol MDI. Participants previously taking budesonide were switched to beclomethasone, but the child's daily dose was not changed. Study period Sequence 1: maintenance beclomethasone inhaler (< 800 μg/d) + placebo inhaler for exacerbation 1, followed by maintenance beclomethasone inhaler + inhaler with beclomethasone to double dose of ICS for exacerbation 2 Sequence 2: maintenance beclomethasone inhaler + inhaler with beclomethasone to double dose of ICS for exacerbation 1. Maintenance beclomethasone inhaler (< 800 μg/d) + placebo inhaler for exacerbation 2 Other medications allowed Salbutamol MDI |
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Outcomes |
Primary outcome: not specified Secondary outcomes
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Notes |
Funding source: New Zealand Asthma Society Funder role: no details about funder's role reported Registration: not registered Ethics approval: approved by Southern Regional Health Authority ethics committee Consent to participate: reports all participants and their parent provided informed consent Trial reporting vs review analysis: study reports need for oral steroids only for those who took their study inhaler, which is suitable for Analysis 1.2. To include in Analysis 1.1, we used the same number of events with the full population denominators. |