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

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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• Patients who are transferred to critical care after enrollment will be withdrawn from the study and continue to receive care according to institutional standard practice.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.