Normalisation of airflow limitation in asthma: Post‐hoc analyses of TRIMARAN and TRIGGER

Clinical and Translational Allergy

G. Walter Canonica¹  J. Christian Virchow²  Andrea Vele³  George Georges³  Dave Singh⁴  Alberto Papi⁵ 

[1] Center of Personalized Medicine: Asthma and Allergy Humanitas University and Research Hospital IRCCS Milan Italy;Departments for Pneumology/Internal Intensive Care Medicine Center for Internal Medicine, University Medicine Rostock Rostock Germany;Global Clinical Development Chiesi Farmaceutici SpA Parma Italy;Medicines Evaluation Unit The University of Manchester, Manchester University NHS Foundation Trust Manchester UK;Respiratory Medicine Unit University of Ferrara, University Hospital S. Anna Ferrara Italy;

关键词: exacerbations;    inhaled corticosteroid;    inhaled triple therapy;    long‐acting muscarinic antagonist;    long‐acting beta2‐agonist;   

DOI  :  10.1002/clt2.12145

来源: DOAJ

【 摘 要 】

Abstract Background In asthma, persistent airflow limitation (PAL) is associated with poorer control, lung function decline and exacerbations. Using post‐hoc analyses we evaluated: the relationship between post‐salbutamol PAL at screening, airflow limitation (AL) during 52 weeks treatment with extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) versus BDP/FF and the risk of moderate/severe asthma exacerbations. Methods TRIMARAN and TRIGGER were double‐blind studies comparing BDP/FF/G with BDP/FF (TRIMARAN medium‐dose ICS; TRIGGER high‐dose) in adults with uncontrolled asthma. Patients were subgrouped according to post‐salbutamol PAL status at screening, and AL over the 52‐week treatment period. Results Most patients with post‐salbutamol PAL at screening had AL at all on‐treatment visits (TRIMARAN 62.8%; TRIGGER 66.8%). A significantly higher proportion of patients had normalised airflow on ≥1 follow‐up visit when receiving BDP/FF/G than BDP/FF (TRIMARAN 44.1 vs. 33.1% [p = 0.003]; TRIGGER 40.1 vs. 26.0% [p < 0.001]). In patients with post‐salbutamol PAL at screening and normalised AL at ≥1 follow‐up visit, exacerbation rates were 15% (p = 0.105) and 19% (p = 0.039) lower in TRIMARAN and TRIGGER versus those with AL on all visits. There was a trend to lower exacerbation rates in patients receiving BDP/FF/G than BDP/FF, particularly in patients in whom AL was normalised. Conclusion In these analyses, AL in asthma was associated with an increased exacerbation incidence. Inhaled triple therapy with extrafine BDP/FF/G was more likely to normalise airflow, and was associated with a trend to a lower exacerbation rate than BDP/FF, particularly in the subgroup of patients in whom treatment was associated with airflow normalisation. ClinicalTrials.gov: TRIMARAN, NCT02676076; TRIGGER, NCT02676089.

【 授权许可】

Unknown