{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T21:24:59Z","timestamp":1788902699972,"version":"build-2803163510"},"reference-count":0,"publisher":"Jaypee Brothers Medical Publishing","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAPI"],"published-print":{"date-parts":[[2025,11,10]]},"abstract":"<jats:p>Background: India bears a significant burden of asthma, and asthma in India is characterized \nby high mortality rates. Poor adherence to treatment guidelines is observed. Several inhaled \ncorticosteroid (ICS) with long-acting beta (\u03b2) 2 agonist (LABA) combinations are commercially \nmarketed in India, formoterol fumarate\u2013fluticasone propionate being one of them. Real-world \nIndian studies on fluticasone-formoterol from India are scarce. This study aims to evaluate the \neffectiveness and safety of formoterol fumarate (6 \u00b5g) and fluticasone propionate (250 \u00b5g) \nadministered through a dry powder inhaler (DPI) or metered-dose inhaler (MDI) in Indian asthma \npatients.\nMaterials and methods: This 24-week prospective, multicenter study (CTRI\/2023\/08\/056250) \nevaluated Formoflo 250 (formoterol fumarate 6 \u00b5g with fluticasone propionate 250 \u00b5g) transcaps \n(DPI), and Formoflo 250 transhaler (MDI) in adults aged 18\u201365 years. The primary endpoint was \nthe mean change in trough forced expiratory volume in 1 second (FEV1) at week-24. Secondary \nendpoints included changes in trough forced vital capacity (FVC), asthma control test (ACT), and \nasthma quality of life questionnaire (AQLQ) scores. Safety was assessed through adverse events \n(AEs) and asthma exacerbations, with appropriate statistical analyses conducted on the modified \nintention-to-treat (mITT) population.\nResults: A total of 503 patients were enrolled, with 495 included in the mITT analysis and all 503 in \nthe safety analysis. At week-24, a mean increase of 312.2 \u00b1 121.1 mL was observed in trough FEV1, \nwhile trough FVC improved by 279.3 \u00b1 147.3 mL (p &lt; 0.0001). The mean ACT score increased by \n11.6 \u00b1 3.7 (p &lt; 0.0001), while the mean AQLQ score improved by 2.5 \u00b1 1.2 (p &lt; 0.0001) at week-24. \nAdverse events were reported in 7.0% of patients, primarily mild, with no serious AEs or fatalities. \nThe findings were consistent across both Formoflo DPI and MDI formulations.\nConclusion: The combination of formoterol fumarate and fluticasone propionate significantly \nimproved lung function, asthma control, and quality of life, demonstrating marked effectiveness \nand safety with both DPI and MDI in Indian asthma patients.<\/jats:p>","DOI":"10.59556\/japi.73.1251","type":"journal-article","created":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T11:47:56Z","timestamp":1766058476000},"page":"54-63","source":"Crossref","is-referenced-by-count":1,"title":["Evaluating the Real-world Effectiveness and Safety of  Formoterol Fumarate and Fluticasone Propionate Combination  in Asthma: A Prospective, Multicenter Study"],"prefix":"10.59556","volume":"73","author":[{"given":"Shital","family":"Patil","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajesh","family":"Venkitakrishnan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarat K","family":"Behera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul K","family":"Jalan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish Kumar","family":"Jain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samadarshi","family":"Dutta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronak","family":"Panwala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kundan","family":"Nivangune","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamlesh","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2914","published-online":{"date-parts":[[2025,11,10]]},"container-title":["Journal of the Association of Physicians of India"],"original-title":[],"deposited":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T11:47:59Z","timestamp":1766058479000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.japi.org\/article\/japi-73-11-54"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,10]]},"references-count":0,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2025,11,10]]},"published-print":{"date-parts":[[2025,11,10]]}},"URL":"https:\/\/doi.org\/10.59556\/japi.73.1251","relation":{},"ISSN":["0004-5772"],"issn-type":[{"value":"0004-5772","type":"print"}],"subject":[],"published":{"date-parts":[[2025,11,10]]}}}