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 United Kingdom.
Trial registration: EUPAS30940. Registered August 13, 2019.
Keywords: ADEPT, Anonymized data ethics & protocol transparency; AR, Allergic rhinitis; ATS, American Thoracic society; BEC, Blood eosinophil count; CRS, Chronic rhinosinusitis; Control; ERS, European respiratory society; Exacerbations; FEV1, forced expiratory volume in 1 s; FVC, Forced vital capacity; GERD, Gastroesophageal reflux disease; GINA, Global initiative for asthma; ICS, Inhaled corticosteroid; INS, Intranasal corticosteroid; NP, Nasal polyps; OAC, Overall asthma control; OAH, Oral anti-histamine; OCS, Oral corticosteroid; OPCRD, Optimum patient care research database; OTC, Over the counter; PEF, Peak expiratory flow rate; RCT, Randomized controlled trial; RDAC, Risk domain asthma control; Rescue medication; SABA, Short-acting β2-agonist; SMD, Standardised mean difference; UK, United Kingdom.
© 2020 The Authors.