CopdPhase 4Sundial-COPDNCT05292053
Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations
A Phase 4 study testing TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation in people with Copd, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- What is being tested?
- TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 9 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
- Documented Bilateral Oophorectomy
- Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age appropriate, greater than 45 years, in the absence of hormone replacement therapy). In questionable cases for women less than 60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's postmenopausal reference range is confirmatory. Females under 60 years of age, who are on HRT and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, subjects can resume use of HRT during the study without use of a highly effective method to avoid pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Health Research Institute
Dallas, Texas, 75246
About this study
Official title: Establishing Outcomes of Once-Daily ICS/LABA/LAMA Plus PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (SUNDIAL-COPD)
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.
Read the detailed description
TRELEGY ELLIPTA is not prescribed as standard of care. Study participants will be consented prior to being prescribed TRELEGY ELLIPTA as part of this study.
Subjects will be given TRELEGY ELLIPTA once daily at the same time every day (± 2 hours). TRELEGY ELLIPTA will be initiated the morning of enrollment if feasible, or the morning following hospital enrollment otherwise. It will be administered as 1 inhalation by the orally inhaled route only.
When exacerbations of COPD that require hospitalization occur, short-acting bronchodilators (both beta agonists and anticholinergics) are routinely prescribed as part of a comprehensive regimen that includes supplemental oxygen, parenteral corticosteroids, antibiotics (usually), and if severe, non-invasive positive pressure ventilation. According to GOLD 2018 recommendations,2 long-acting bronchodilators are to be introduced as soon as possible prior to discharge from the hospital if not continued during hospitalization. However, the recommendation to use short-acting bronchodilators as a primary therapeutic inhalant is based on grade C level of evidence, suggesting a paucity of data to support that position. Primarily related to pharmacy-driven cost considerations, the exclusive use of short-acting bronchodilators has become the standard of care in treating hospitalized patients with COPD exacerbations, with the introduction of long-acting inhalants only upon discharge, by a number of institutions including Ben Taub Hospital in Houston (Nicola Hanania MD: personal communication), and throughout the Baylor Scott and White Healthcare System in Texas. This therapeutic substitution of short-acting for long-acting bronchodilators has been estimated to result in a cost savings of ~$400k at Baylor University Medical Center alone (personal communication: director of pharmacy services). Even so, few if any studies have evaluated the length of stay, in-hospital adverse events (nocturnal awakenings related to respiratory symptoms that occur beyond the window of pharmacologic efficacy of short-acting medications), respiratory therapy utilization or the potential impact upon re-hospitalizations with this paradigm shift of care. Sanford Hospital System in North Dakota recently published a study comparing a once daily long-acting combination with compared with a twice-daily combination and saw minimal cost savings and no real change in outcomes.3 This same system had previously studied substitution of twice daily beta agonist and once daily anticholinergic bronchodilators for combination short-acting bronchodilators and found improved outcomes and cost savings but reported their results in a non-peer reviewed journal in AARC Times, November 2011.
Results of an analysis of 60 patient charts randomly selected after hospitalization at Baylor University Medical Center for an exacerbation of underlying airways disease (greater than 90% with COPD) showed tremendous variation in practice patterns; with 30% of patients receiving short-acting beta-antagonists and muscarinic agonists (SABA/SAMA) only, 70% receiving long-acting beta-antagonists (LABA) with PRN SABA/SAMA, and only 42% receiving a long-acting muscarinic agonist (LAMA), despite practice guidelines encouraging the use of SABA/SAMA only (typically 4 times daily and as needed).
It is this large variability that renders the evaluation and interpretation of institution-specific outcomes difficult. The main impetus for the proposed study is therefore to establish a more standardized open-label protocol which would allow for a more accurate assessment of intervention outcomes. As one of several secondary goals of this study, the investigators aim to compare key outcomes (including, number of PRN treatments, length of hospital stay, and rate of readmission) with those from the historical cohort described above, when a combination LABA/LAMA/ICS inhaler is used as the primary scheduled daily inhaled therapy
- Conditions
- Copd
- Being tested
- TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for InhalationDrug
Also called trelegy ellipta
TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder)
| Study group | Role | What they receive |
|---|---|---|
| COPD subjects | Experimental | COPD with or without asthma Receives: Drug: TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Hospital Length of Stay
The hospital length of stay for patients admitted with the diagnosis of COPD exacerbation
Measured: 60 days
Number of Participants With Readmissions
Number of participants who were readmitted to the hospital within 30 days of study completion.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Jul 2022
- Primary completion9 Sep 2024
- Study completion9 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Mark Millard, Baylor Research Institute
- Investigators
- Mark W Millard, MD, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292053
- Sponsor's protocol ID
- 021-182
- Acronym
- Sundial-COPD
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2022
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23349446Riley 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.
PubMed 30806700Gaduzo 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.
PubMed 30863039Jones 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.
PubMed 38421013Petite 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.
PubMed 30923404Wedzicha 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.
PubMed 28298398Wilson 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.
PubMed 23973659Celli 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.
PubMed 15219010Sagana 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/
PubMed 35901227Lindenauer 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.
PubMed 25423006Ohar 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.
PubMed 35023914Lee 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.
PubMed 39969937Khamooshi 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.
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.
PubMed 12556250Ruan 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.
PubMed 36528962
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Outcomes of Once-Daily ICS/LABA/LAMA Plus PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (SUNDIAL-COPD)
- ClinicalTrials.gov ID
- NCT05292053
- Acronym / sponsor ID
- Sundial-COPD / 021-182
- Conditions
- Copd
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TRELEGY ELLIPTA is not prescribed as standard of care. Study participants will be consented prior to being prescribed TRELEGY ELLIPTA as part of this study.
Subjects will be given TRELEGY ELLIPTA once daily at the same time every day (± 2 hours). TRELEGY ELLIPTA will be initiated the morning of enrollment if feasible, or the morning following hospital enrollment otherwise. It will be administered as 1 inhalation by the orally inhaled route only.
When exacerbations of COPD that require hospitalization occur, short-acting bronchodilators (both beta agonists and anticholinergics) are routinely prescribed as part of a comprehensive regimen that includes supplemental oxygen, parenteral corticosteroids, antibiotics (usually), and if severe, non-invasive positive pressure ventilation. According to GOLD 2018 recommendations,2 long-acting bronchodilators are to be introduced as soon as possible prior to discharge from the hospital if not continued during hospitalization. However, the recommendation to use short-acting bronchodilators as a primary therapeutic inhalant is based on grade C level of evidence, suggesting a paucity of data to support that position. Primarily related to pharmacy-driven cost considerations, the exclusive use of short-acting bronchodilators has become the standard of care in treating hospitalized patients with COPD exacerbations, with the introduction of long-acting inhalants only upon discharge, by a number of institutions including Ben Taub Hospital in Houston (Nicola Hanania MD: personal communication), and throughout the Baylor Scott and White Healthcare System in Texas. This therapeutic substitution of short-acting for long-acting bronchodilators has been estimated to result in a cost savings of ~$400k at Baylor University Medical Center alone (personal communication: director of pharmacy services). Even so, few if any studies have evaluated the length of stay, in-hospital adverse events (nocturnal awakenings related to respiratory symptoms that occur beyond the window of pharmacologic efficacy of short-acting medications), respiratory therapy utilization or the potential impact upon re-hospitalizations with this paradigm shift of care. Sanford Hospital System in North Dakota recently published a study comparing a once daily long-acting combination with compared with a twice-daily combination and saw minimal cost savings and no real change in outcomes.3 This same system had previously studied substitution of twice daily beta agonist and once daily anticholinergic bronchodilators for combination short-acting bronchodilators and found improved outcomes and cost savings but reported their results in a non-peer reviewed journal in AARC Times, November 2011.
Results of an analysis of 60 patient charts randomly selected after hospitalization at Baylor University Medical Center for an exacerbation of underlying airways disease (greater than 90% with COPD) showed tremendous variation in practice patterns; with 30% of patients receiving short-acting beta-antagonists and muscarinic agonists (SABA/SAMA) only, 70% receiving long-acting beta-antagonists (LABA) with PRN SABA/SAMA, and only 42% receiving a long-acting muscarinic agonist (LAMA), despite practice guidelines encouraging the use of SABA/SAMA only (typically 4 times daily and as needed).
It is this large variability that renders the evaluation and interpretation of institution-specific outcomes difficult. The main impetus for the proposed study is therefore to establish a more standardized open-label protocol which would allow for a more accurate assessment of intervention outcomes. As one of several secondary goals of this study, the investigators aim to compare key outcomes (including, number of PRN treatments, length of hospital stay, and rate of readmission) with those from the historical cohort described above, when a combination LABA/LAMA/ICS inhaler is used as the primary scheduled daily inhaled therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | Experimental | Drug: TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for InhalationCOPD with or without asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for InhalationAlso: trelegy elliptaTRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder) | Drug | COPD subjects |
Primary outcome
Number of PRN Respiratory Therapy Drugs Per Day (PRN Treatments With Short Acting Bronchodilators Via Nebulization Given by Respiratory Therapists).
Time frame: 30 days
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
2 secondary outcomes
Hospital Length of Stay
Time frame: 60 days
Number of Participants With Readmissions
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23349446Piquet 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: PubMed 30806700Riley 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: PubMed 30863039Gaduzo 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: PubMed 38421013Jones 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: PubMed 30923404Petite 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: PubMed 28298398Wedzicha 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: PubMed 23973659Wilson 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: PubMed 15219010Celli 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: PubMed 35901227Sagana 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: PubMed 25423006Lindenauer 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: PubMed 35023914Ohar 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: PubMed 39969937Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W Millard, MD principal investigator
Baylor Scott and White Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation in people with Copd, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PRN Respiratory Therapy Drugs Per Day (PRN Treatments With Short Acting Bronchodilators Via Nebulization Given by Respiratory Therapists). (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292053, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.