Status:
COMPLETED
Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Copd
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 nebul...
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 onc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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- Patients who are transferred to critical care after enrollment will be withdrawn from the study and continue to receive care according to institutional standard practice.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 Patients will be withdrawn if BiPAP settings are changed after enrollment.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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05292053
Start Date
July 1 2022
End Date
February 9 2025
Last Update
November 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Scott & White Health Research Institute
Dallas, Texas, United States, 75246