Effect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial. Issue 12 (15th August 2022)

• Record Type: Journal Article
• Authors: Thompson, Philip J.; Criner, Gerard J.; Dransfield, Mark T.; Halpin, David M. G.; Han, MeiLan K.; Lipson, David A.; Maghzal, Ghassan J.; Martinez, Fernando J.; Midwinter, Dawn; Singh, Dave; Tombs, Lee; Wise, Robert A.
• Is Part Of: Respirology. Volume 27:Issue 12(2022)
• Page Start: 1034
• Page End: 1044
• Publication Date: 2022-08-15
• Subjects: chronic mucus hypersecretion -- chronic obstructive pulmonary disease -- clinical outcomes -- COPD -- single‐inhaler triple therapy; Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Periodicals; 612.2
• DOI: 10.1111/resp.14339
• Languages: English
• ISSNs: 1323-7799

Abstract

Abstract: Background and objective: Chronic mucus hypersecretion (CMH) is a clinical phenotype of COPD. This exploratory post hoc analysis assessed relationship between CMH status and treatment response in IMPACT. Methods: Patients were randomized to once‐daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 μg, FF/VI 100/25 μg or UMEC/VI 62.5/25 μg and designated CMH+ if they scored 1/2 in St George's Respiratory Questionnaire (SGRQ) questions 1 and 2. Endpoints assessed by baseline CMH status included on‐treatment exacerbation rates, change from baseline in trough forced expiratory volume in 1 second, SGRQ total score, COPD Assessment Test (CAT) score, proportion of SGRQ and CAT responders at Week 52 and safety. Results: Of 10, 355 patients in the intent‐to‐treat population, 10, 250 reported baseline SGRQ data (CMH+: 62% [ n = 6383]). FF/UMEC/VI significantly ( p < 0.001) reduced on‐treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in CMH+ (rate ratio: 0.87 and 0.72) and CMH− patients (0.82 and 0.80). FF/UMEC/VI significantly ( p < 0.05) reduced on‐treatment severe exacerbation rates versus UMEC/VI in CMH+ (0.62) and CMH− (0.74) subgroups. Similar improvements in health status and lung function with FF/UMEC/VI were observed, regardless of CMH status. In CMH+ patients, FF/VI significantly ( p < 0.001) reduced on‐treatment moderate/severe and severe exacerbation rates versus UMEC/VI (0.83 and 0.70). Conclusion: FF/UMEC/VI had a favourable benefit: risk profile versus dual therapies irrespective of CMH status. The presence of CMH did not influence treatment response or exacerbations, lung function and/or health status. However, CMH did generate differences when dual therapies were compared and the impact of CMH should be considered in future trial design. Abstract : The relationship between chronic mucus hypersecretion (CMH) and treatment response to FF/UMEC/VI, FF/VI or UMEC/VI was assessed in symptomatic patients with COPD and a history of exacerbations. FF/UMEC/VI reduced exacerbation rates versus FF/VI and UMEC/VI irrespective of CMH status; similar improvements in health status and lung function were observed. See related Editorial