Extrafine triple therapy and asthma exacerbation seasonality: TRIMARAN and TRIGGER post hoc analyses

BackgroundPrevious studies have shown seasonal variation in asthma exacerbations, peaking over the winter months. A single-inhaler triple therapy containing extrafine formulations of inhaled corticosteroid (ICS) beclomethasone dipropionate (BDP), long-acting β2-agonist formoterol fumarate (FF), and muscarinic antagonist glycopyrronium (G) is development for asthma.ObjectiveWe sought to evaluate whether calendar season impacted relative effect BDP/FF/G versus BDP/FF on moderate severe exacerbations.MethodsTRIMARAN TRIGGER were double-blind 52-week comparing with (TRIMARAN medium-dose ICS; high-dose) adults uncontrolled (Asthma Control Questionnaire-7 score ≥1.5), prebronchodilator FEV1 less than 80% predicted, history 1 or more exacerbation, who had been receiving ICS/long-acting at least 4 weeks before entry. Moderate exacerbations captured throughout each study. In these post hoc analyses, annual exacerbation rate was calculated month, ratios determined from events grouped by season.ResultsIn patients received alone, there a marked occurrence highest However, addition component reduced this variation, especially during winter, such that greatest (significant 20.3% reduction [P = .0008]). Reductions other seasons ranged between 8.6% 12.0%.ConclusionsThese analyses indicate reduces peaks confirm overall utility adding management asthma. Previous We exacerbations. TRIMARAN season. 12.0%. These