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Early asthma prophylaxis, natural history, skeletal development and economy (EASE): a pilot randomised controlled trial |
Baxter-Jones AD, Helms PJ, Russell G, Grant A, Ross S, Cairns JA, Ritchie L, Taylor R, Reid DM, Osman LM, Robins S, Fletcher ME |
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Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Baxter-Jones AD, Helms PJ, Russell G, Grant A, Ross S, Cairns JA, Ritchie L, Taylor R, Reid DM, Osman LM, Robins S, Fletcher ME. Early asthma prophylaxis, natural history, skeletal development and economy (EASE): a pilot randomised controlled trial. Health Technology Assessment 2000; 4(28): 1-89 Authors' objectives The objectives of this study are: - To establish recruitment rates of newly presenting asthmatic children. - To establish acceptability of study protocols. - To pilot age-specific quality of life (QoL) assessment. - To assess short-term (6 months) outcomes of inhaled corticosteroids (ICS) treatment. - To refine sample size calculations for a definitive study.
Authors' conclusions Most (96%) of the proposed sample was recruited, and the low drop-out rate (8%) demonstrated acceptability of the study protocol. Most children first presenting with symptoms suggestive of asthma were <6 years old and represented a group biased towards mild to moderate asthma, or virally induced wheeze. The caregivers QoL questionnaire was found to better reflect a child's symptom changes than a child-centred instrument. In the short term, no adverse effects were seen on growth, but ICS treatment significantly reduced bone metabolism. Most of the young children with asthma/wheeze improved over time with beta2-agonist treatment alone, and clinical benefits of early ICS intervention amongst these children were not detected; however, there was inadequate power in this pilot study to establish this. Calculation from the outcomes indicated a trial of 300 children would be required to determine treatment effects at 90% power.
Indexing Status Subject indexing assigned by CRD MeSH Adrenal Cortex Hormones; Asthma; Child Language Published English Country of organisation England Address for correspondence NETSCC, Health Technology Assessment, Alpha House, University of Southampton Science Park, Southampton, SO16 7NS UK Tel: +44 23 8059 5586 Email: hta@hta.ac.uk AccessionNumber 32000000922 Date bibliographic record published 01/12/2000 Date abstract record published 01/12/2000 |
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