Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations

Summary

This is a single-center, prospective, open-label study evaluating outcomes of TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder) on PRN nebulized short-acting beta agonist (SABA) treatment in hospitalized subjects with COPD with or without asthma. Approximately 80 adult subjects with COPD with or without asthma will take part in this study at this location. Subjects will be given TRELEGY ELLIPTA, placed on a consistent short-term systemic corticosteroid therapy, and followed until 30 days post hospital discharge. This study will not include patients with rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.

Timeline

Start

2022-07-01

Primary completion

2024-09-09

Completion

2025-02-09

Publications

• Background Piquet J, Chavaillon JM, David P, Martin F, Blanchon F, Roche N; French College of General Hospital Respiratory Physicians (CPHG). High-risk patients following hospitalisation for an acute exacerbation of COPD. Eur Respir J. 2013 Oct;42(4):946-55. doi: 10.1183/09031936.00180312. Epub 2013 Jan 24.
• Background Riley CM, Sciurba FC. Diagnosis and Outpatient Management of Chronic Obstructive Pulmonary Disease: A Review. JAMA. 2019 Feb 26;321(8):786-797. doi: 10.1001/jama.2019.0131.
• Background Gaduzo S, McGovern V, Roberts J, Scullion JE, Singh D. When to use single-inhaler triple therapy in COPD: a practical approach for primary care health care professionals. Int J Chron Obstruct Pulmon Dis. 2019 Feb 13;14:391-401. doi: 10.2147/COPD.S173901. eCollection 2019.
• Background Jones P, Alzaabi A, Casas Herrera A, Polatli M, Rabahi MF, Cortes Telles A, Aggarwal B, Acharya S, Hasnaoui AE, Compton C. Understanding the Gaps in the Reporting of COPD Exacerbations by Patients: A Review. COPD. 2024 Dec;21(1):2316594. doi: 10.1080/15412555.2024.2316594. Epub 2024 Feb 29.
• Background Petite SE, Murphy JA. Evaluation of Bronchodilator Use During Chronic Obstructive Pulmonary Disease Exacerbation Inpatient Admissions. Hosp Pharm. 2019 Apr;54(2):112-118. doi: 10.1177/0018578718769569. Epub 2018 Apr 10.
• Background Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3):1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar.
• Background Wilson R, Sethi S, Anzueto A, Miravitlles M. Antibiotics for treatment and prevention of exacerbations of chronic obstructive pulmonary disease. J Infect. 2013 Dec;67(6):497-515. doi: 10.1016/j.jinf.2013.08.010. Epub 2013 Aug 22.
• Background Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available.
• Background Sagana RL, Wesorick DH, Byrne BT, Fitzgerald LJ, Georgia TE, Mack M, Wesorick D, Proudlock A. Care of the Hospitalized Patient with Acute Exacerbation of COPD [Internet]. Ann Arbor (MI): Michigan Medicine University of Michigan; 2022 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK582288/
• Background Lindenauer PK, Shieh MS, Pekow P, Stefan MS. Reply: long-acting bronchodilators in patients with chronic obstructive pulmonary disease: still more to know. Ann Am Thorac Soc. 2014 Nov;11(9):1505. doi: 10.1513/AnnalsATS.201410-451LE. No abstract available.
• Background Ohar JA, Ferguson GT, Mahler DA, Drummond MB, Dhand R, Pleasants RA, Anzueto A, Halpin DMG, Price DB, Drescher GS, Hoy HM, Haughney J, Hess MW, Usmani OS. Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2022 Jan 6;17:79-92. doi: 10.2147/COPD.S319511. eCollection 2022.
• Background Lee RW, Millard MW. The Failure of an Auto-Substitution Protocol of Short-Acting Nebulizers for Long-Acting Inhalers to Reduce Cost of Care in a Quaternary Teaching Hospital. Respir Care. 2025 May;70(5):469-476. doi: 10.1089/respcare.12385. Epub 2025 Jan 29.
• Background Khamooshi P, Shaka, Hafeez, Velazquez, Genaro, Ovie, Okorare, Obiaigwe, Happiness, Mohamoud, Iman. Rate and Reasons for 30-Day Readmission Following COPD: A United States Analysis CHEST. 2021;160(4):A1899.
• Background Stoller JK, Orens DK, Kester L. Missed bronchodilator medication treatments in respiratory therapy: frequency and underlying causes. Respir Care. 2003 Feb;48(2):110-4.
• Background Ruan H, Zhang H, Wang J, Zhao H, Han W, Li J. Readmission rate for acute exacerbation of chronic obstructive pulmonary disease: A systematic review and meta-analysis. Respir Med. 2023 Jan;206:107090. doi: 10.1016/j.rmed.2022.107090. Epub 2022 Dec 13.
• Background Ruan H, Zhao H, Wang J, Zhang H, Li J. All-cause readmission rate and risk factors of 30- and 90-day after discharge in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231202742. doi: 10.1177/17534666231202742.
• Background Vogelmeier CF, Beeh KM, Schultze M, Kossack N, Richter LM, Claussen J, Compton C, Noorduyn SG, Ismaila AS, Requena G. Evaluation of Adherence and Persistence to Triple Therapy in Patients with COPD: A German Claims Data Study. Int J Chron Obstruct Pulmon Dis. 2024 Aug 9;19:1835-1848. doi: 10.2147/COPD.S460903. eCollection 2024.
• Background Kong CW, Wilkinson TMA. Predicting and preventing hospital readmission for exacerbations of COPD. ERJ Open Res. 2020 May 11;6(2):00325-2019. doi: 10.1183/23120541.00325-2019. eCollection 2020 Apr.

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