{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T07:49:23Z","timestamp":1791618563873,"version":"4.3.4"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T00:00:00Z","timestamp":1769040000000},"content-version":"vor","delay-in-days":905,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Novartis Pharma AG"},{"name":"Novartis Pharma AG"}],"content-domain":{"domain":["www.atsjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,8,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>CFTR (cystic fibrosis transmembrane conductance regulator) dysfunction is associated with mucus accumulation and worsening chronic obstructive pulmonary disease (COPD) symptoms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The aim of this phase IIb dose-finding study was to compare a CFTR potentiator, icenticaftor (QBW251), with placebo in patients with COPD and chronic bronchitis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with COPD on triple therapy for at least three months were randomized to six treatment arms (icenticaftor 450, 300, 150, 75, or 25\u2009mg or placebo twice daily [b.i.d.]) in a 24-week, multicenter, parallel-group, double-blind study. The primary endpoint was change from baseline in trough FEV1 after 12\u2009weeks. Secondary endpoints included change from baseline in trough FEV1 and Evaluating Respiratory Symptoms in COPD (E-RS) total and cough and sputum scores after 24\u2009weeks. Multiple comparison procedure-modeling was conducted to characterize dose\u2013response relationship. Rescue medication use, exacerbations, and change in serum fibrinogen concentration after 24\u2009weeks were assessed in exploratory and post hoc analyses, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>Nine hundred seventy-four patients were randomized. After 12\u2009weeks of icenticaftor treatment, no dose\u2013response relationship for change from baseline in trough FEV1 was observed; however, it was observed for E-RS cough and sputum score. A dose\u2013response relationship was observed after 24\u2009weeks for trough FEV1, E-RS cough and sputum and total scores, rescue medication use, and fibrinogen. A dose of 300\u2009mg b.i.d. was consistently the most effective. Improvements for 300\u2009mg b.i.d. versus placebo were also seen in pairwise comparisons of these endpoints. All treatments were well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The primary endpoint was negative, as icenticaftor did not improve trough FEV1 over 12\u2009weeks. Although the findings must be interpreted with caution, icenticaftor improved trough FEV1; reduced cough, sputum, and rescue medication use; and lowered fibrinogen concentrations at 24\u2009weeks.<\/jats:p>\n                    <jats:p>Clinical trial registered with www.clinicaltrials.gov (NCT 04072887).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.202303-0458oc","type":"journal-article","created":{"date-parts":[[2023,7,6]],"date-time":"2023-07-06T17:10:43Z","timestamp":1688663443000},"page":"417-427","update-policy":"https:\/\/doi.org\/10.1164\/crossmarkpolicies","source":"Crossref","is-referenced-by-count":45,"title":["Icenticaftor, a CFTR Potentiator, in COPD: A Multicenter, Parallel-Group, Double-Blind Clinical Trial"],"prefix":"10.1093","volume":"208","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2412-3182","authenticated-orcid":false,"given":"Fernando J.","family":"Martinez","sequence":"first","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine\/NewYork-Presbyterian Hospital, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard J.","family":"Criner","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Gessner","sequence":"additional","affiliation":[{"name":"Institute for Clinical Immunology, University of Leipzig, Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margret","family":"Jandl","sequence":"additional","affiliation":[{"name":"Hamburger Institut f\u00fcr Therapieforschung GmbH, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Scherbovsky","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n Scherbovsky, Mendoza, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaharu","family":"Shinkai","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas M.","family":"Siler","sequence":"additional","affiliation":[{"name":"Midwest Chest Consultants, PC, St. Charles, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus F.","family":"Vogelmeier","sequence":"additional","affiliation":[{"name":"Department of Medicine, Pulmonary and Critical Care Medicine, University of Marburg, German Center for Lung Research, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Voves","sequence":"additional","affiliation":[{"name":"Private Practice, Bismarckstra\u00dfe, Feldbach, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jadwiga A.","family":"Wedzicha","sequence":"additional","affiliation":[{"name":"National Heart and Lung Institute, Imperial College London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Bartels","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Bottoli","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Byiers","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Cardenas","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joerg H.","family":"Eckert","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian S.","family":"Gutzwiller","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Knorr","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahavir","family":"Kothari","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt. 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