Abstract
Introduction In mild asthma, as-needed budesonide–formoterol is superior or noninferior to maintenance budesonide plus as-needed short-acting β2-agonist in reducing severe exacerbations. In this pre-specified analysis, we investigated patterns of inhaled corticosteroid (ICS) and β2-agonist use in PRACTICAL, a randomised controlled trial.
Methods Participants were randomised 1:1 to as-needed budesonide–formoterol (200/6 μg Turbuhaler, one actuation) or maintenance budesonide (200 μg Turbuhaler, one actuation twice a day) with as-needed terbutaline (250 μg, two actuations) 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 β2-agonist use. One actuation of budesonide–formoterol was considered to be an equivalent bronchodilator dose as two actuations of terbutaline.
Results 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 μg, 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 β2-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 days, respectively).
Conclusions The timing of ICS dose when self-titrated to β2-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 β2-agonist.
Abstract
In mild asthma, the timing of the ICS dose, when self-titrated through the vehicle of β2-agonist reliever use, is more important than total ICS dose in reducing severe exacerbation risk, when associated with greater overall as-needed β2-agonist use https://bit.ly/2Zs5CJV
Footnotes
This article has supplementary material available from erj.ersjournals.com
De-identified individual participant data collected during the PRACTICAL trial (Australian New Zealand Clinical Trials Registry identifier ACTRN12616000377437) will be shared beginning 2 years after article publication with no end date. These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to Richard Beasley via e-mail (richard.beasley{at}mrinz.ac.nz) and will be reviewed by the PRACTICAL study management committee. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.
Conflict of interest: C. Baggott reports grants from the Health Research Council of New Zealand, during the conduct of the study; support for meeting attendance from AstraZeneca and Novartis, outside the submitted work.
Conflict of interest: J. Hardy reports grants from the Health Research Council of New Zealand, during the conduct of the study; travel costs from AstraZeneca, outside the submitted work.
Conflict of interest: J. Sparks reports grants from the Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: M. Holliday reports grants from the Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: D. Hall reports grants from the Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: A. Vohlidkova reports grants from the Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: R. Hancox reports grants from the Health Research Council of New Zealand, during the conduct of the study; support for meeting attendance from AstraZeneca and Boehringer Ingelheim, fees for lectures from Menarini, outside the submitted work.
Conflict of interest: M. Weatherall reports grants from the Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: J. Fingleton reports grants from the Health Research Council of New Zealand, during the conduct of the study; grants, personal fees for lectures and support for meeting attendance from AstraZeneca, grants and personal fees for lectures from GlaxoSmithKline, grants from Genentech, personal fees for lectures and support for meeting attendance from Boehringer Ingelheim, outside the submitted work.
Conflict of interest: R. Beasley reports grants from the Health Research Council of New Zealand, during the conduct of the study; grants and personal fees from AstraZeneca and GlaxoSmithKline, grants from Genentech, personal fees from Avillion and Theravance, outside the submitted work.
Support statement: The PRACTICAL study was funded through a programme grant (15/573) provided by the Health Research Council of New Zealand to the study sponsor, the Medical Research Institute of New Zealand (MRINZ). The MRINZ had overall responsibility for the study conduct, monitoring and data management. The randomised medications were purchased commercially. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received January 26, 2020.
- Accepted May 17, 2020.
- Copyright ©ERS 2020
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