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. 2022 Sep 26;2022(9):CD007524. doi: 10.1002/14651858.CD007524.pub5

Garrett 1998.

Study characteristics
Methods  
  • Randomised, double‐blind, placebo‐controlled, cross‐over trial

  • Single centre based in New Zealand

  • Compared efficacy of an increased dose of inhaled corticosteroid used within the context of an asthma self‐management plan for treating exacerbations of asthma

  • Recruitment year(s) not specified

  • 26 weeks from baseline to endpoint


 
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.
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
Outcomes Primary outcome: not specified
Secondary outcomes
  • Morning and evening PEFR

  • Diurnal PEFR variability

  • Morning and evening symptom scores of cough and wheeze

  • Activity symptom score

  • Spirometric function including FEV1, FVC, and FEF25-75

  • Opinion score on effectiveness of the study inhaler as judged by parents

  • Adverse events such as hospitalisation or oral corticosteroid requirement

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.