Abstract
Background In mild asthma, as-needed budesonide-formoterol is superior or non-inferior to maintenance budesonide plus as-needed short-acting beta2-agonist in reducing severe exacerbations. In this pre-specified analysis, we investigated patterns of inhaled corticosteroid (ICS) and beta2-agonist use in PRACTICAL, a randomised controlled trial.
Methods Participants were randomised 1:1 to as-needed budesonide-formoterol (200/6 mcg Turbuhaler, 1 prn) or maintenance budesonide (200 mcg Turbuhaler, 1 bd) with as-needed terbutaline (250 mcg, 2 prn) for 52 weeks; 110 participants had electronic monitors attached to their study inhalers which captured the time and date of every actuation. Key outcome measures were patterns of ICS and beta2-agonist use. One actuation of budesonide-formoterol was considered to be an equivalent bronchodilator dose as two actuations of terbutaline.
Findings Participants randomised to as-needed budesonide-formoterol had more days with no ICS use compared with maintenance budesonide (median total days of no use 156 versus 22 days respectively), lower median daily budesonide dose (164 versus 328 mcg respectively), and a greater median number of days of ≥4 budesonide actuations (4 versus 1 days respectively). Participants randomised to as-needed budesonide-formoterol took higher equivalent doses of beta2-agonist both overall (median number of actuations 0.8 versus 0.3 per day respectively) and in response to worsening asthma (total number of “overuse days” of >8 or >16 actuations of budesonide-formoterol or terbutaline 33 versus 10 respectively).
Interpretation The timing of ICS dose when self-titrated to beta2-agonist use is more important than total ICS dose in reducing severe exacerbation risk in mild asthma, when associated with greater overall use of as-needed beta2-agonist.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Baggott reports grants from Health Research Council of New Zealand, during the conduct of the study; non-financial support from Astra Zeneca, non-financial support from Novartis, outside the submitted work.
Conflict of interest: Dr. Hardy reports grants from Health Research Council of New Zealand, during the conduct of the study; other from Astra Zeneca, outside the submitted work.
Conflict of interest: Ms. Sparks reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: Mr. Holliday reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: Dr. Hall reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: Dr. Vohlidkova reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: Dr. Hancox reports grants from Health Research Council of New Zealand, during the conduct of the study; other from Astra Zeneca, other from Menarini, other from Boehringer Ingelheim, outside the submitted work.
Conflict of interest: Prof. Weatherall reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: Dr. Fingleton reports grants from Health Research Council of New Zealand, during the conduct of the study; grants, personal fees and non-financial support from AstraZeneca, grants and personal fees from GlaxoSmithKline, grants from Genentech, personal fees and non-financial support from Boerhinger Ingleheim, outside the submitted work.
Conflict of interest: Dr. Beasley reports grants from Health Research Council of New Zealand, during the conduct of the study; grants and personal fees from AstraZeneca, grants and personal fees from GlaxoSmithKline, grants from Genentech, personal fees from Avillion, personal fees from Theravance, outside the submitted work.
- Received January 26, 2020.
- Accepted May 17, 2020.
- Copyright ©ERS 2020
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