Abstract
Symptom-driven low-dose inhaled corticosteroid–formoterol is safe and effective in mild asthma and has been recommended as one of the preferred treatment regimens at steps 1 and 2 in the 2019 update of the Global Initiative for Asthma. However, there are no data on patient preferences for this regimen.
A subgroup of participants in the PRACTICAL study (ACTRN12616000377437), a randomised controlled trial comparing symptom-driven budesonide–formoterol with maintenance budesonide plus as-needed terbutaline completed a survey on treatment preferences, satisfaction, beliefs and experience at their final study visit.
306 (75%) out of 407 eligible participants completed the survey. Regimen preference was strongly associated with randomised treatment, as were preferences for and beliefs about preventer inhaler use. Combination preventer and reliever as-needed therapy was preferred by 135 (90%, 95% CI 85.2–94.8%) out of 150 who were randomised to as-needed budesonide–formoterol, and by 63 (40%, 95% CI 32.7–48.1%) out of 156 who were randomised to maintenance budesonide. By contrast, twice-daily preventer inhaler with a reliever inhaler as required was preferred by 15 (10%) out of 150 of those randomised to as-needed budesonide–formoterol and 93 (60%) out of 156 of those randomised to maintenance budesonide. Satisfaction with all study inhalers was high. Of patients randomised to as-needed budesonide–formoterol 92% (n=138) were confident using it as a reliever at the end of the study.
Although most participants preferred the regimen to which they had been randomised, this association was much stronger for those randomised to budesonide–formoterol as needed, indicating that most patients preferred as-needed corticosteroid–formoterol therapy if they had experienced it.
Abstract
In a clinical trial of patients with mild–moderate asthma comparing as-needed budesonide–formoterol with maintenance budesonide plus as-needed terbutaline, as-needed budesonide–formoterol was preferred by 90% of patients randomised to this treatment http://bit.ly/37DdUzB
Footnotes
This article has supplementary material available from erj.ersjournals.com
This trial is registered with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) with identifier number ACTRN12616000377437; UTN: U1111-1174-2273. Data availability: de-identified individual participant preference data collected during the PRACTICAL trial 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 R. Beasley via email (richard.beasley@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 Health Research Council of New Zealand, during the conduct of the study; personal fees for meeting attendance from AstraZeneca and Novartis, outside the submitted work.
Conflict of interest: H.K. Reddel reports grants from Health Research Council of New Zealand, during the conduct of the study; grants and personal fees for consultancy, advisory board and data monitoring committee work, and educational activities from AstraZeneca, grants, personal fees for consultancy, advisory board and data monitoring committee work, and educational activities and non-financial support (study medication) from GlaxoSmithKline, personal fees for data monitoring committee work from Merck, grants and personal fees for advisory board and data monitoring committee work, and educational activities from Novartis, personal fees for educational activities from Teva and Mundipharma, personal fees for educational activities and advisory board work from Boehringer Ingelheim, outside the submitted work; and is Chair of the GINA Scientific Committee.
Conflict of interest: J. Hardy reports grants from Health Research Council of New Zealand, during the conduct of the study; personal fees for meeting attendance from AstraZeneca, outside the submitted work.
Conflict of interest: J. Sparks reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: M. Holliday reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: A. Corin reports grants from Health Research Council of New Zealand, during the conduct of the study; grants and personal fees for meeting attendance from AstraZeneca, personal fees for lectures and meeting attendance from GlaxoSmithKline, grants from resTORbio, Regeneron, Esperion, Connect Biopharma and Luitpold, and is a committee member for PHARMAC, outside the submitted work.
Conflict of interest: B. Montgomery reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: J. Reid reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: D. Sheahan reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: R.J Hancox reports grants from Health Research Council of New Zealand, during the conduct of the study; grants and reimbursement of travel expenses from AstraZeneca, reimbursement of travel expenses from Boehringer Ingelheim, personal fees for lectures from Menarini, outside the submitted work.
Conflict of interest: M. Weatherall reports grants from Health Research Council of New Zealand, during the conduct of the study.
Conflict of interest: R. Beasley reports grants from Health Research Council of New Zealand, during the conduct of the study; grants and personal fees for lectures, advisory board work and meeting attendance from AstraZeneca, grants from GlaxoSmithKline and Genentech, personal fees for advisory board work from Theravance, outside the submitted work.
Conflict of interest: J. Fingleton reports grants from Health Research Council of New Zealand, during the conduct of the study; grants, personal fees for lectures and non-financial (travel) support from AstraZeneca, grants from GlaxoSmithKline and Genentech, personal fees for lectures and non-financial (travel) support from Boehringer Ingelheim, outside the submitted work.
Support statement: The 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). MRINZ had overall responsibility for the study conduct, monitoring, and data management. The funder had no role in the design, data collection, data analysis or interpretation, or writing of the manuscript. All authors had full access to the data analysis report, assisted in the writing of the manuscript and approved the final version. The randomised medications were purchased commercially. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received October 23, 2019.
- Accepted January 22, 2020.
- Copyright ©ERS 2020