PT  - JOURNAL ARTICLE
AU  - Amy Nuttall
AU  - Emma Wilkinson
AU  - William Bedson
AU  - Ian Sinha
AU  - Paul Mcnamara
TI  - A systematic review of the proportion of adolescents recruited to RCTs of asthma treatments for adults and adolescents
AID  - 10.1183/13993003.congress-2021.PA3921
DP  - 2021 Sep 05
TA  - European Respiratory Journal
PG  - PA3921
VI  - 58
IP  - suppl 65
4099  - http://erj.ersjournals.com/content/58/suppl_65/PA3921.short
4100  - http://erj.ersjournals.com/content/58/suppl_65/PA3921.full
SO  - Eur Respir J2021 Sep 05; 58
AB  - Background: To guide adolescent asthma management, evidence from RCTs of treatment efficacy and safety is needed for this age group. The EMA recommends adolescents are included in adult asthma RCTs.Aims and objectives: To evaluate in published RCTs of pharmaceutical asthma therapies that recruit both adolescents and adults:1. The proportion of adolescents recruited2. Whether therapies studied are subsequently licenced for adolescents and/or adultsMethods: Multiple databases were systematically searched for RCTs of asthma therapies recruiting adolescents and adults published between 2015-20. Three authors assessed reporting of: proportion of adolescents, age of youngest participant, and conclusions drawn regarding use of each therapy in adolescence. NICE guidelines were reviewed to assess whether therapies were approved to treat asthma in adolescents and/or adults.Results: 58 RCTs were identified. In 34(59%) of these, proportion of adolescents recruited was not reported. In 37(64%), age of youngest participant was not reported. Of the 24(41%) trials where proportion of adolescents was reported, this ranged between 1-49%(median 6%). Only 6(10%) trials reported adolescent sub-group data. 22 different therapies were studied, of which NICE approved 12 for use in adolescents and adults and a further 6 in adults only.Conclusions: In published asthma RCTs, it is frequently unclear whether adolescents have been recruited. Furthermore, when reported, the proportion is often minimal. Consequently, caution is needed when using data from some RCTs to support management decisions in adolescents with asthma.FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA3921.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).