Background: MP-AzeFlu (Dymista®; spray of azelastine/fluticasone propionate) is the most effective allergic rhinitis (AR) treatment available. Its effect on asthma outcomes in patients with AR and asthma is unknown.
Methods: This pre-post historical cohort study, using the Optimum Patient Care Research Database, included patients aged ≥ 12 years, from UK general practice with active asthma (defined as a recorded diagnosis, with ≥1 prescription for reliever or controller inhaler) in the year before or at the initiation date. The primary study outcome was change in number of acute respiratory events (i.e. exacerbation or antibiotic course for a respiratory event) between baseline and outcome years. The effect size of MP-AzeFlu was quantified as the difference in % of patients that improved and worsened.
Results: Of the 1,188 patients with AR and asthma included, many had a record of irreversible obstruction (67%), and uncontrolled asthma (70.4%), despite high mean daily doses of reliever/controller therapy and acute oral corticosteroid use, in the year pre-MP-AzeFlu initiation. MP-AzeFlu initiation was associated with fewer acute respiratory events (effect size (e)=5.8%, p=0.0129) and a reduction in daily use of short-acting β2-agonists, with fewer patients requiring >2 SABA puffs/week (e=7.7% p<0.0001). More patients had well-controlled asthma 1-year post-MP-AzeFlu initiation (e=4.1%; p=0.0037), despite a reduction in inhaled corticosteroids (e=4.8%; p=0.0078).
Conclusions: This study provides the first direct evidence of the beneficial effect of MP-AzeFlu on asthma outcomes in co-morbid patients in primary care in the UK.
Trial registration: EUPAS30940. Registered 13 August 2019.
This study was supported by funding from BGP Products Operations GmbH (A MylanCompany). BGP Products Operations GmbH was given the opportunity to review the manuscript for medical and scientific accuracy as well as for intellectual property considerations.
The dataset supporting the conclusions of this article was derived from the Optimum Patient Care Research Database (www.opcrd.co.uk). The OPCRD has ethical approval from the National Health Service (NHS) Research Authority to hold and process anonymized research data (Research Ethics Committee reference: 15/EM/0150). This study was approved by the Anonymized Data Ethics Protocols and Transparency (ADEPT) committee – the independent scientific advisory committee for the OPCRD. The authors do not have permission to give public access to the study dataset; researchers may request access to OPCRD data for their own purposes. Access to OCPRD can be made via the OCPRD website (https://opcrd.co.uk/our-database/data-requests/) or via the enquiries email firstname.lastname@example.org.
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