{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T03:59:53Z","timestamp":1762142393950,"version":"3.41.2"},"reference-count":37,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100005890","name":"ministry of health of the people\u2019s republic of china","doi-asserted-by":"publisher","award":["201002008"],"award-info":[{"award-number":["201002008"]}],"id":[{"id":"10.13039\/501100005890","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Respir Dis"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Patients diagnosed with chronic obstructive pulmonary disease (COPD) in China are commonly prescribed ipratropium plus theophylline (I+T) therapy. Studies have shown that an inhaled corticosteroid (ICS)\/long-acting \u03b2<jats:sup>2<\/jats:sup>-agonist (LABA) combination is also efficacious in reducing symptoms and exacerbations. This study evaluated the efficacy and tolerability of adding budesonide\/formoterol (BUD\/FORM) to I+T in Chinese patients with severe COPD. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> A randomized, parallel-group, open-label, multicenter phase IV study (Clinical Trials.gov identifier: NCT01415518) was conducted in China. Patients received either BUD\/FORM (160\/4.5\u2009\u00b5g; two inhalations twice daily [bid] via Turbuhaler<jats:sup>\u00ae<\/jats:sup>) + I (20\u2009\u00b5g per inhalation, two inhalations four times daily) + T (100\u2009mg bid) or I+T alone for 12\u2009weeks. The primary efficacy variable was change from baseline in predose forced expiratory volume in 1\u2009s (FEV<jats:sub>1<\/jats:sub>). <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> A total of 584 patients were randomized equally between treatment groups. At the end of the study, the BUD\/FORM plus I+T group displayed significant improvements in predose FEV<jats:sub>1<\/jats:sub> versus the I+T group (between-group difference 6.9%; 95% confidence interval [CI]: 4.3, 9.6; p &lt; 0.0001). Forced vital capacity, inspiratory capacity, peak expiratory flow and health-related quality of life (HRQoL) scores were significantly improved (all p\u2009&lt;\u20090.0001) and exacerbation frequency was reduced (43.5% reduction; rate ratio 0.565, 95% CI 0.325, 0.981; p\u2009=\u20090.0425) with BUD\/FORM plus I+T versus I+T alone. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Patients with severe COPD in China treated with BUD\/FORM plus I+T showed significant improvements in lung function and HRQoL and a reduction in exacerbations compared with I+T alone. Both treatments were well tolerated and no safety concerns were noted. The reviews of this paper are available via the supplemental material section. <\/jats:p><\/jats:sec>","DOI":"10.1177\/1753466619853500","type":"journal-article","created":{"date-parts":[[2019,6,26]],"date-time":"2019-06-26T10:04:28Z","timestamp":1561543468000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":10,"title":["The efficacy of adding budesonide\/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China"],"prefix":"10.1177","volume":"13","author":[{"given":"Kewu","family":"Huang","sequence":"first","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, China"},{"name":"Beijing Institute of Respiratory Medicine, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanfei","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Beijing Hospital, Ministry of Health, Dongdan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jian","family":"Kang","sequence":"additional","affiliation":[{"name":"The First Hospital of China Medical University, Heping, Shenyang, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"An","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China"},{"name":"Beijing Institute of Respiratory Medicine, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zeguang","family":"Zheng","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Guangzhou Medical University, Yuexiu, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lijun","family":"Ma","sequence":"additional","affiliation":[{"name":"Henan Provincial People\u2019s Hospital, Zhengzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liping","family":"Peng","sequence":"additional","affiliation":[{"name":"Jilin University First Hospital, Changchun, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongyang","family":"Wang","sequence":"additional","affiliation":[{"name":"Hebei United University Affiliated Hospital, Tangshan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rong","family":"Su","sequence":"additional","affiliation":[{"name":"Global Medicines Development, AstraZeneca, Shanghai, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yohji","family":"Itoh","sequence":"additional","affiliation":[{"name":"Biometrics, AstraZeneca, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7857-5435","authenticated-orcid":false,"given":"Chen","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pulmonary and Critical Care Medicine, Beijing Hospital, China"},{"name":"Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China"},{"name":"National Clinical Research Center for Respiratory Diseases, Beijing, China"},{"name":"Department of Respiratory Medicine, Capital Medical University, Beijing, China"},{"name":"Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2019,6,26]]},"reference":[{"key":"bibr1-1753466619853500","unstructured":"World Health Organization. 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