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. 2024 Jan:221:107478.
doi: 10.1016/j.rmed.2023.107478. Epub 2023 Nov 24.

Systematic literature review of traits and outcomes reported in randomised controlled trials of asthma with regular dosing of inhaled corticosteroids with short-acting β2-agonist reliever, as-needed ICS/formoterol, or ICS/formoterol maintenance and reliever therapy

Nicolas Roche  1 , Arzu Yorgancıoğlu  2 , Alvaro A Cruz  3 , Gabriel Garcia  4 , Kim L Lavoie  5 , P G Abhijith  6 , Manish Verma  7 , Anurita Majumdar  8 , Swarnendu Chatterjee  9
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Free article

Systematic literature review of traits and outcomes reported in randomised controlled trials of asthma with regular dosing of inhaled corticosteroids with short-acting β2-agonist reliever, as-needed ICS/formoterol, or ICS/formoterol maintenance and reliever therapy

Nicolas Roche et al. Respir Med. 2024 Jan.
Free article

Abstract

Introduction: Asthma treatments based solely on diagnostic label do not benefit patients equally. To identify patient traits that may be associated with improved treatment response to regular inhaled corticosteroid (ICSs) dosing with short-acting β2-agonist reliever or ICS/formoterol-containing therapy, a systematic literature review (SLR) was conducted.

Methods: Searches of databases including MEDLINE and Embase identified randomised controlled trials (RCTs) of patients with asthma, aged ≥12 years, published 1998-2022, containing ≥1 regular ICS dosing or ICS/formoterol-containing treatment arm, and reporting patient traits and outcomes of interest. Relevant data was extracted and underwent a feasibility assessment to determine suitability for meta-analysis.

Results: The SLR identified 39 RCTs of 72,740 patients and 90 treatment arms, reporting 11 traits and 11 outcomes. Five patient traits (age, body mass index, FEV1, smoking history, asthma control) and five outcomes (exacerbation rate, lung function, asthma control, adherence, time to first exacerbation) were deemed feasible for inclusion in meta-analyses due to sufficient comparable reporting. Subgroups of clinical outcomes stratified by levels of patient traits were reported in 16 RCTs.

Conclusion: A systematic review of studies of regular ICS dosing with SABA or ICS/formoterol-containing treatment strategies in asthma identified consistent reporting of five traits and outcomes, allowing exploration of associations with treatment response. Conversely, many other traits and outcomes, although being potentially relevant, were inconsistently reported and limited subgroup reporting meant analyses of treatment response for subgroups of traits was not possible. We recommend more consistent measurement and reporting of clinically relevant patient traits and outcomes in respiratory RCTs.

Keywords: Maintenance therapy; Reliever therapy; Respiratory clinical trials; Treatable traits.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Nicolas Roche has received grants and personal fees from Boehringer Ingelheim, Novartis, Pfizer, GSK and personal fees from Austral, Biosency, MSD, AstraZeneca, Chiesi, Sanofi, Zambon. Arzu Yorgancıoğlu has received research grants from Novartis, MSD, AstraZeneca, and Sanofi, and has acted as a speaker/consultant for AstraZeneca, Abdi İbrahim, GSK, Novartis, Chiesi and Bilim. Alvaro Cruz has received personal fees from GSK, AstraZeneca, Sanofi, Boehringer Ingelheim, Chiesi, Crossjet, Eurofarma, Abdi Ibrahim and Glennmark. Gabriel Garcia has received research grants from Novartis, GSK, Boehringer Ingelheim, AstraZeneca, and Sanofi, and for acting as a consultant/advisor/speaker for GSK, AstraZeneca, Novartis, and Sanofi. Kim L. Lavoie has received consulting fees/speaker fees from GSK, AbbVie, Boehringer Ingelheim, Janssen, Bausch, Astellas, Novartis, AstraZeneca, X-Facto, and Sojecci Inc. Abhijith PG was employed by GSK at the time of the study. Manish Verma, Anurita Majumdar and Swarnendu Chatterjee are full time employees of GSK and hold stocks/shares in GSK.

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