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

NCT05292053 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-21

Study results available
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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

Interventions

DRUG

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

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Mark W Millard, MD · Baylor Scott and White Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-09-09
Completion
2025-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05292053 on ClinicalTrials.gov