{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T04:07:30Z","timestamp":1791691650216,"version":"4.3.4"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2022,5,1]],"date-time":"2022-05-01T00:00:00Z","timestamp":1651363200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Respivant Sciences Inc."},{"name":"Respivant Sciences Inc."}],"content-domain":{"domain":["www.atsjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Chronic cough remains a major and often debilitating symptom for patients with idiopathic pulmonary fibrosis (IPF). In a phase 2A study, inhaled RVT-1601 (cromolyn sodium) reduced daytime cough and 24-hour average cough counts in patients with IPF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine the efficacy, safety, and optimal dose of inhaled RVT-1601 for the treatment of chronic cough in patients with IPF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicenter, randomized, placebo-controlled phase 2B study, patients with IPF and chronic cough for \u2a7e8 weeks were randomized (1:1:1:1) to receive 10, 40, and 80 mg RVT-1601 three times daily or placebo for 12 weeks. The primary endpoint was change from baseline to end of treatment in log-transformed 24-hour cough count. Key secondary endpoints were change from baseline in cough severity and cough-specific quality of life. Safety was monitored throughout the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>The study was prematurely terminated owing to the impact of the coronavirus disease (COVID-19) pandemic. Overall, 108 patients (mean age 71.0 years, 62.9% males) received RVT-1601 10 mg (n\u2009=\u200929), 40 mg (n\u2009=\u200925), 80 mg (n\u2009=\u200927), or matching placebo (n\u2009=\u200927); 61.1% (n\u2009=\u200966) completed double-blind treatment. No statistically significant difference was observed in the least-square mean change from baseline in log-transformed 24-hour average cough count, cough severity, and cough-specific quality of life score between the RVT-1601 groups and the placebo group. The mean percentage change from baseline in 24-hour average cough count was 27.7% in the placebo group. Treatment was generally well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Treatment with inhaled RVT-1601 (10, 40, and 80 mg three times a day) did not provide benefit over placebo for the treatment of chronic cough in patients with IPF.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1164\/rccm.202106-1485oc","type":"journal-article","created":{"date-parts":[[2022,1,20]],"date-time":"2022-01-20T13:54:56Z","timestamp":1642686896000},"page":"1084-1092","update-policy":"https:\/\/doi.org\/10.1164\/crossmarkpolicies","source":"Crossref","is-referenced-by-count":25,"title":["Phase 2B Study of Inhaled RVT-1601 for Chronic Cough in Idiopathic Pulmonary Fibrosis: A Multicenter, Randomized, Placebo-controlled Study (SCENIC Trial)"],"prefix":"10.1093","volume":"205","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2412-3182","authenticated-orcid":false,"given":"Fernando J.","family":"Martinez","sequence":"first","affiliation":[{"name":"Department of Medicine, Weill Cornell Medical Center, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlies S.","family":"Wijsenbeek","sequence":"additional","affiliation":[{"name":"Centre for Interstitial Lung Diseases and Sarcoidosis, Department of Respiratory Medicine, Erasmus University Medical Centre, Rotterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Raghu","sequence":"additional","affiliation":[{"name":"Center for Interstitial Lung Diseases, Department of Medicine, and"},{"name":"Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin R.","family":"Flaherty","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, University of Michigan Health System, Ann Arbor, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toby M.","family":"Maher","sequence":"additional","affiliation":[{"name":"Inflammation, Repair and Development Section, National Heart and Lung Institute, Imperial College, London, United Kingdom"},{"name":"National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton Hospital, London, United Kingdom"},{"name":"Hastings Centre for Pulmonary Research and Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wim A.","family":"Wuyts","sequence":"additional","affiliation":[{"name":"Unit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kreuter","sequence":"additional","affiliation":[{"name":"Center for Interstitial and Rare Lung Diseases, Department of Pulmonology, Thoraxklinik, University of Heidelberg, Heidelberg, Germany"},{"name":"German Center for Lung Research, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3837-1467","authenticated-orcid":false,"given":"Martin","family":"Kolb","sequence":"additional","affiliation":[{"name":"Firestone Institute for Respiratory Health, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel C.","family":"Chambers","sequence":"additional","affiliation":[{"name":"School of Clinical Medicine, the University of Queensland, Brisbane, Queensland, Australia"},{"name":"Queensland Lung Transplant Program, the Prince Charles Hospital, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Fogarty","sequence":"additional","affiliation":[{"name":"Spartanburg Medical Research, Spartanburg, South Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nesrin","family":"Mogulkoc","sequence":"additional","affiliation":[{"name":"Department of Chest Diseases, Faculty of Medicine, Ege University, Izmir, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmet S.","family":"Tutuncu","sequence":"additional","affiliation":[{"name":"Respivant Sciences, Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Richeldi","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Meiche e Chirurgiche, Fondazione Policlinico Universitario \u201cA. 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