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Randomized Controlled Trial
. 2014 Aug;19(6):842-51.
doi: 10.1111/resp.12319. Epub 2014 Jun 2.

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Janine Pilcher  1 , Mitesh Patel, Ann Smith, Cheryl Davies, Alison Pritchard, Justin Travers, Peter Black, Mark Weatherall, Richard Beasley, Matire Harwood; SMART Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Combination budesonide/formoterol inhaler as maintenance and reliever therapy in Māori with asthma

Janine Pilcher et al. Respirology. 2014 Aug.

Abstract

Background and objective: There are significant health disparities between Māori and non-Māori with asthma, a pattern seen between other ethnic populations. This study investigates outcomes for Māori in a randomized controlled trial (RCT) of combination budesonide/formoterol inhaler therapy in asthma.

Methods: This 24-week multicentre RCT recruited 303 adult asthma patients, 44 of whom were Māori. Participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ('SMART') regimen or 'standard' regimen (combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever). Outcomes included patterns of beta-agonist inhaler use including 'high use' of reliever therapy (>8 actuations of budesonide/formoterol in excess of four maintenance doses per day for SMART and >16 actuations per day of salbutamol for standard). Differences in outcomes for Māori versus non-Māori were assessed using an interaction term between ethnicity and treatment.

Results: With adjustment for ethnicity, the SMART group had fewer days of high use (relative rate (RR) 0.57 (95% confidence interval (CI): 0.38-0.85)), days of high use without medical review within 48 h (RR 0.49 (95% CI: 0.32-0.75)) and severe exacerbations (RR 0.54 (95% CI: 0.36-0.81)) compared with standard. The magnitude of the benefit from the SMART regimen was similar in Māori and non-Māori. Regardless of treatment regimen, Māori demonstrated more days of high use, high use without medical review and underuse of maintenance therapy.

Conclusions: The SMART regimen has a favourable risk/benefit profile in Māori. Days of high use, days of high use without medical review and underuse of maintenance treatment were greater in Māori, regardless of treatment regimen.

Keywords: Māori; asthma; health disparity; randomized controlled trial; single combination budesonide/formoterol inhaler as maintenance and reliever therapy.

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