Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials

Lee Hatter*, Claire Houghton, Pepa Bruce, Mark Holliday, Allie Eathorne, Ian Pavord, Helen K. Reddel, Robert J. Hancox, Irene Braithwaite, Karen Oldfield, Alberto Papi, Mark Weatherall, Richard Beasley

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
25 Downloads (Pure)

Abstract

Background In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta 2 -agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score. Objective To assess the levels and changes in asthma control for as-needed budesonide-formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials. Methods The number and proportion of participants at study end in each ACQ-5 category ('well-controlled', 'partly controlled' or 'inadequately controlled' symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide-formoterol and maintenance budesonide plus SABA treatment were calculated. Results With last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide-formoterol group had 'well-controlled' or 'partly controlled' symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide-formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively. Conclusions There were no clinically important differences in the proportions of patients with 'well-controlled' or 'partly controlled' asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide-formoterol versus maintenance budesonide plus SABA.

Original languageEnglish
Article numbere001271
Pages (from-to)1-9
Number of pages9
JournalBMJ Open Respiratory Research
Volume9
Issue number1
DOIs
Publication statusPublished - 25 Aug 2022
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Asthma
  • Inhaler devices

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