{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T05:24:43Z","timestamp":1764221083964,"version":"3.46.0"},"reference-count":27,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T00:00:00Z","timestamp":1764028800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019992","name":"Glenmark Pharmaceuticals Limited","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100019992","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["ARM"],"abstract":"<jats:p>Chronic obstructive pulmonary disease (COPD) is a major health burden in India with limited real-world data on triple inhaler therapy. This prospective, open-label, multi-center, single-arm, phase 4 study (October 2023\u2013August 2024) assessed the effectiveness and safety of glycopyrronium\/formoterol fumarate\/budesonide (GFB) triple therapy, administered as metered-dose inhaler (MDI) or dry-powder inhaler (DPI), in Indian COPD patients. Symptomatic patients aged \u226540 years with minimum one exacerbation in the past year and receiving dual or monotherapy were included. GFB was delivered as MDI or DPI based on physician and patient preference. Primary outcomes were changes from baseline in trough forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and modified medical research council (mMRC) score over 24 weeks, with assessment of exacerbations, hospitalizations, rescue medication use, and safety. In 184 patients (70.65% male, mean age 53.7 years), GFB significantly improved FEV1, FVC, and mMRC scores. Eleven mild exacerbations were reported without hospitalization; 17.39% used rescue salbutamol largely in the first 4 weeks. GFB was well tolerated, with mild-to-moderate adverse events in 14.67%, and outcomes were comparable between MDI and DPI. Our findings support GFB as safe and effective treatment in real-world COPD management.<\/jats:p>","DOI":"10.3390\/arm93060053","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T16:31:54Z","timestamp":1764088314000},"page":"53","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness and Safety of Glycopyrronium\u2013Formoterol\u2013Budesonide Triple Therapy in Chronic Obstructive Pulmonary Disease (AIR-FORCE): An Open-Label Multi-Centric Phase 4 Study"],"prefix":"10.3390","volume":"93","author":[{"given":"Anjali R.","family":"Nath","sequence":"first","affiliation":[{"name":"Citizen Hospital, Bangalore 560002, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adesh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Respiratory Medicine, Uttar Pradesh University of Medical Sciences (UPUMS), Etawah 206130, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amit Suresh","family":"Bhate","sequence":"additional","affiliation":[{"name":"Medicine Department, Jeevan Rekha Hospital, Belagavi 590002, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bharat","family":"Mehrotra","sequence":"additional","affiliation":[{"name":"New Leelamani Hospital, Kanpur 208001, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deependra Kumar","family":"Rai","sequence":"additional","affiliation":[{"name":"Respiratory Medicine, All India Institute of Medical Sciences (AIIMS), Patna 801507, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vijay Kumar","family":"Barge","sequence":"additional","affiliation":[{"name":"Medicine Department, Rajarshee Chhatrapati Shahu Maharaj Government Medical College Chhatrapati Pramila Raje Hospital (RCSM), Kolhapur 416012, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-7111-6844","authenticated-orcid":false,"given":"Divya","family":"Bhojwani","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Glenmark Pharmaceuticals, Ltd., Mumbai 400099, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sagar","family":"Bhagat","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Glenmark Pharmaceuticals, Ltd., Mumbai 400099, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8940-8175","authenticated-orcid":false,"given":"Sumit","family":"Bhushan","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Glenmark Pharmaceuticals, Ltd., Mumbai 400099, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saiprasad","family":"Patil","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Glenmark Pharmaceuticals, Ltd., Mumbai 400099, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanmant","family":"Barkate","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Glenmark Pharmaceuticals, Ltd., Mumbai 400099, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,25]]},"reference":[{"key":"ref_1","unstructured":"(2025, March 21). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: 2024 Report: Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available online: https:\/\/goldcopd.org\/wp-content\/uploads\/2024\/02\/GOLD-2024_v1.2-11Jan24_WMV.pdf."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Wang, Z., Lin, J., Liang, L., Huang, F., Yao, X., Peng, K., Gao, Y., and Zheng, J. (2025). Global, regional, and national burden of chronic obstructive pulmonary disease and its attributable risk factors from 1990 to 2021: An analysis for the Global Burden of Disease Study 2021. Respir. Res., 26.","DOI":"10.1186\/s12931-024-03051-2"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"506","DOI":"10.4103\/lungindia.lungindia_159_21","article-title":"Prevalence of chronic obstructive pulmonary disease in India: A systematic review and meta-analysis","volume":"38","author":"Daniel","year":"2021","journal-title":"Lung India"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"503","DOI":"10.4103\/lungindia.lungindia_579_21","article-title":"What is the true burden of chronic obstructive pulmonary disease in India and what are its implications at a national level?","volume":"38","author":"Salvi","year":"2021","journal-title":"Lung India"},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Oba, Y., Keeney, E., Ghatehorde, N., and Dias, S. (2018). Dual combination therapy versus long-acting bronchodilators alone for chronic obstructive pulmonary disease (COPD): A systematic review and network meta-analysis. Cochrane Database Syst. Rev., 12.","DOI":"10.1002\/14651858.CD012620.pub2"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"4408","DOI":"10.21037\/jtd.2019.10.65","article-title":"Management of chronic obstructive pulmonary disease-A position statement of the South African Thoracic Society: 2019 update","volume":"11","author":"Calligaro","year":"2019","journal-title":"J. Thorac. Dis."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/S2213-2600(13)70052-3","article-title":"Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): A randomised, double-blind, parallel-group study","volume":"1","author":"Wedzicha","year":"2013","journal-title":"Lancet Respir. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"741","DOI":"10.1164\/rccm.200904-0492OC","article-title":"Efficacy and tolerability of budesonide\/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease","volume":"180","author":"Welte","year":"2009","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1076","DOI":"10.1016\/S0140-6736(18)30206-X","article-title":"Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): A double-blind, parallel group, randomised controlled trial","volume":"391","author":"Papi","year":"2018","journal-title":"Lancet"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Bardsley, S., Criner, G.J., Halpin, D.M.G., Han, M.K., Hanania, N.A., Hill, D., Lange, P., Lipson, D.A., Martinez, F.J., and Midwinter, D. (2022). Single-inhaler triple therapy fluticasone furoate\/umeclidinium\/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis. Respir. Med, 205.","DOI":"10.1016\/j.rmed.2022.107040"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"2417","DOI":"10.2147\/COPD.S370540","article-title":"Comparative Adherence and Persistence of Single- and Multiple-Inhaler Triple Therapies Among Patients with Chronic Obstructive Pulmonary Disease in an English Real-World Primary Care Setting","volume":"17","author":"Halpin","year":"2022","journal-title":"Int. J. Chronic Obstr. Pulm. Dis."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"79","DOI":"10.2147\/COPD.S291030","article-title":"Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate\/Formoterol Fumarate\/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial","volume":"16","author":"Beeh","year":"2021","journal-title":"Int. J. Chronic Obstr. Pulm. Dis."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Wedzicha, J.A.E.C.-C., Miravitlles, M., Hurst, J.R., Calverley, P.M., Albert, R.K., Anzueto, A., Criner, G.J., Papi, A., Rabe, K.F., and Rigau, D. (2017). Management of COPD exacerbations: A European Respiratory Society\/American Thoracic Society guideline. Eur. Respir. J., 49.","DOI":"10.1183\/13993003.00791-2016"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"747","DOI":"10.1016\/S2213-2600(18)30327-8","article-title":"Triple therapy with budesonide\/glycopyrrolate\/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): A double-blind, parallel-group, multicentre, phase 3 randomised controlled trial","volume":"6","author":"Ferguson","year":"2018","journal-title":"Lancet Respir. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1056\/NEJMoa1916046","article-title":"Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD","volume":"383","author":"Rabe","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1671","DOI":"10.1056\/NEJMoa1713901","article-title":"Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD","volume":"378","author":"Lipson","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1919","DOI":"10.1016\/S0140-6736(17)30188-5","article-title":"Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): A double-blind, parallel group, randomised controlled trial","volume":"389","author":"Vestbo","year":"2017","journal-title":"Lancet"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"51","DOI":"10.2147\/POR.S396830","article-title":"Clinical Management of COPD in the Real World: Can Studies Reveal Errors in Management and Pathways to Improve Patient Care?","volume":"14","author":"Halpin","year":"2023","journal-title":"Pragmatic Obs. Res."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Muro, S., Kawayama, T., Sugiura, H., Seki, M., Duncan, E.A., Bowen, K., Marshall, J., Megally, A., and Patel, M. (2024). Benefits of budesonide\/glycopyrronium\/formoterol fumarate dihydrate on lung function and exacerbations of COPD: A post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history. Respir. Res., 25.","DOI":"10.1186\/s12931-024-02918-8"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Singh, D., Rabe, K.F., Martinez, F.J., Kr\u00fcll, M., Jenkins, M., Patel, M., and Dorinsky, P. (2022). Relationship between prior inhaled corticosteroid use and benefits ofbudesonide\/glycopyrronium\/formoterol fumarate dihydrate on exacerbations, symptoms, health-related quality of life, and lung function in patients with chronic obstructive pulmonary disease: Analyses from the ETHOS study. Respir. Med., 197.","DOI":"10.1016\/j.rmed.2022.106857"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1164\/rccm.202312-2311OC","article-title":"Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS)","volume":"211","author":"Singh","year":"2025","journal-title":"Am. J. Respir. Crit. Care Med."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Zheng, J., Baldi, S., Zhao, L., Li, H., Lee, K.H., Singh, D., Papi, A., Grapin, F., Guasconi, A., and Georges, G. (2021). Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: The TRIVERSYTI randomised controlled trial. Respir. Res., 22.","DOI":"10.1186\/s12931-021-01683-2"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1153","DOI":"10.2147\/COPD.S452624","article-title":"Budesonide\/Glycopyrrolate\/Formoterol for the Management of COPD in a UK Primary Care Population: Real-World Use and Early Medication Success","volume":"19","author":"Chan","year":"2024","journal-title":"Int. J. Chronic Obstr. Pulm. Dis."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"2245","DOI":"10.2147\/COPD.S432963","article-title":"Exacerbations and Real-World Outcomes After Single-Inhaler Triple Therapy of Budesonide\/Glycopyrrolate\/Formoterol Fumarate, Among Patients with COPD: Results from the EROS (US) Study","volume":"18","author":"Strange","year":"2023","journal-title":"Int. J. Chronic Obstr. Pulm. Dis."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"650","DOI":"10.1016\/j.amjmed.2024.11.007","article-title":"Effectiveness of Single Versus Multiple Inhaler Triple Therapy on Mortality and Cardiopulmonary Risk Reduction in COPD: The SKOPOS-MAZI Study","volume":"138","author":"Pollack","year":"2025","journal-title":"Am. J. Med."},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Calder\u00f3n-Montero, A., de Miguel Diez, J., de Sim\u00f3n Guti\u00e9rrez, R., Campos T\u00e9llez, S., Chac\u00f3n Moreno, A.D., Alonso Avil\u00e9s, R., Gonz\u00e1lez Alonso, N., Montero Sol\u00eds, A., and Escribano Pardo, D. (2025). Triple inhaled therapy of formoterol\/glycopyrrolate\/budesonide reduces the use of oral corticosteroids and antibiotics during COPD exacerbations in real-world conditions. Semergen, 51.","DOI":"10.1016\/j.semerg.2024.102418"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta5260","article-title":"Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: A systematic review of the literature","volume":"5","author":"Brocklebank","year":"2001","journal-title":"Health Technol. Assess."}],"container-title":["Advances in Respiratory Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2543-6031\/93\/6\/53\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T05:20:12Z","timestamp":1764220812000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2543-6031\/93\/6\/53"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,25]]},"references-count":27,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["arm93060053"],"URL":"https:\/\/doi.org\/10.3390\/arm93060053","relation":{},"ISSN":["2543-6031"],"issn-type":[{"type":"electronic","value":"2543-6031"}],"subject":[],"published":{"date-parts":[[2025,11,25]]}}}