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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
dc.contributor.authorThompson, Philip J.
dc.contributor.authorCriner, Gerard J.
dc.contributor.authorDransfield, Mark T.
dc.contributor.authorHalpin, David M. G.
dc.contributor.authorHan, MeiLan K.
dc.contributor.authorLipson, David A.
dc.contributor.authorMaghzal, Ghassan J.
dc.contributor.authorMartinez, Fernando J.
dc.contributor.authorMidwinter, Dawn
dc.contributor.authorSingh, Dave
dc.contributor.authorTombs, Lee
dc.contributor.authorWise, Robert A.
dc.date.accessioned2022-12-05T16:38:46Z
dc.date.available2024-01-05 11:38:45en
dc.date.available2022-12-05T16:38:46Z
dc.date.issued2022-12
dc.identifier.citationThompson, 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. (2022). "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." Respirology 27(12): 1034-1044.
dc.identifier.issn1323-7799
dc.identifier.issn1440-1843
dc.identifier.urihttps://hdl.handle.net/2027.42/175180
dc.description.abstractBackground and objectiveChronic mucus hypersecretion (CMH) is a clinical phenotype of COPD. This exploratory post hoc analysis assessed relationship between CMH status and treatment response in IMPACT.MethodsPatients 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.ResultsOf 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).ConclusionFF/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.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
dc.publisherJohn Wiley & Sons, Ltd
dc.subject.otherchronic mucus hypersecretion
dc.subject.otherchronic obstructive pulmonary disease
dc.subject.otherclinical outcomes
dc.subject.otherCOPD
dc.subject.othersingle-inhaler triple therapy
dc.titleEffect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelInternal Medicine and Specialties
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/175180/1/resp14339.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/175180/2/resp14339_am.pdf
dc.identifier.doi10.1111/resp.14339
dc.identifier.sourceRespirology
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dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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