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

NCT05292053 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 021-182
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Copd

Outcome Measures

Primary Outcomes (1)

• Number of PRN Respiratory Therapy Drugs Per Day (PRN Treatments With Short Acting Bronchodilators Via Nebulization Given by Respiratory Therapists).

  Number of PRN respiratory therapy treatments in patients hospitalized with the diagnosis of COPD exacerbation receiving once-daily ICS/LABA/LAMA (fluticasone furoate/umeclidinium/vilanterol) therapy

  30 days

Secondary Outcomes (2)

• Hospital Length of Stay

  60 days

• Number of Participants With Readmissions

  30 days

Study Arms (1)

COPD subjects

EXPERIMENTAL

COPD with or without asthma

Drug: TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation

Interventions

TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation DRUG

TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder)

Also known as: trelegy ellipta

COPD subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and capable of providing written informed consent
• Subjects age 18 years or older at time of enrollment
• Diagnosis of COPD with or without asthma for 12 months or more.
• Hospitalized less than or equal to 24 hours prior to enrollment and currently hospitalized for COPD exacerbation with or without asthma
• Able to properly use the Ellipta medication delivery device
• Able to generate greater than or equal to 30 L/min inspiratory flow at screening, measured with an InCheck DIAL adjusted to medium low resistance, to document a subject's ability to effectively inhale medication delivered via an Ellipta device.

You may not qualify if:

• Clinically significant lung disease other than COPD with or without asthma
• Positive SARS-CoV-2 test at the time of ED or hospital admission, or any time between admission and enrollment.
• History of severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients
• Unable to perform inspiratory flow or spirometry procedures
• Critically ill patients, or patients with rapidly deteriorating or life-threatening episodes of COPD or asthma including:
• Patients in critical care unit, or transferred from critical care unit
• Patients who are transferred to critical care after enrollment will be withdrawn from the study and continue to receive care according to institutional standard practice.
• Patients who initiate Bilevel Positive Airway Pressure (BiPAP) after hospitalization
• o Patients who use BiPAP at baseline (prior to COPD exacerbation) may be included if BiPAP settings remain consistent with pre-exacerbation settings. Patients will be withdrawn if BiPAP settings are changed after enrollment.
• Pregnant or lactating women or women of child-bearing potential (WOCBP). Women must meet the non-productive potential definition below to be eligible.
• Non-reproductive potential is defined as
• Pre-menopausal females with one of the following:
• Documented tubal ligation
• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal ligation
• Hysterectomy

Sponsors & Collaborators

• Baylor Research Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Baylor Scott & White Health Research Institute

Dallas, Texas, 75246, United States

Location

Related Publications (18)

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• 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.

  PMID: 30806700 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.

  PMID: 30863039 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.

  PMID: 38421013 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.

  PMID: 30923404 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.

  PMID: 28298398 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.

  PMID: 23973659 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.

  PMID: 15219010 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/

  PMID: 35901227 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.

  PMID: 25423006 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.

  PMID: 35023914 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.

  PMID: 39969937 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.

  PMID: 12556250 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.

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• 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.

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• 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.

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  PMID: 32420313 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Baylor Scott & White Research Institute

Felicia.Padilla@BSWHealth.org

214-820-1771

Study Officials

• Mark W Millard, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Baylor Martha Foster Lung Care Center

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 23, 2022
• Study Start: July 1, 2022
• Primary Completion: September 9, 2024
• Study Completion: February 9, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)