Trial Outcomes & Findings for Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (NCT NCT05292053)

NCT ID: NCT05292053

Last Updated: 2025-11-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-11-21

Participant Flow

There is the option for electronic consenting using study approved methods such as hospital telehealth system, patient ipads, telephone calls/telephone video conferencing. Documents will be sent electronically to the email address provided by the patient. Informed consent will be obtained in a private clinic room, with minimal distraction on the 2nd floor of the Annette C. and Harold C. Simmons in the Sammons Cancer (Suite 250) Center or Roberts Hospital(BUMC).

Participant milestones

Measure	COPD subjects COPD with or without asthma
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	COPD Subjects n=80 Participants COPD with or without asthma
Age, Categorical <=18 years	0 Participants n=68 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=68 Participants
Age, Categorical >=65 years	42 Participants n=68 Participants
Sex: Female, Male Female	36 Participants n=68 Participants
Sex: Female, Male Male	44 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	56 Participants n=68 Participants
Race (NIH/OMB) White	22 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=68 Participants
Region of Enrollment United States	80 Participants n=68 Participants
Number of Economically Disadvantaged Participants	41 Participants n=68 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Overall, 80 eligible patients consented and were included.

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

Outcome measures

Measure	COPD subjects n=80 Participants COPD with or without asthma 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)
Number of PRN Respiratory Therapy Drugs Per Day (PRN Treatments With Short Acting Bronchodilators Via Nebulization Given by Respiratory Therapists).	0.03 treatments per day of admission Interval 0.0 to 0.67

SECONDARY outcome

Timeframe: 60 days

Population: Overall, 80 eligible patients consented and were included.

The hospital length of stay for patients admitted with the diagnosis of COPD exacerbation

Outcome measures

Measure	COPD subjects n=80 Participants COPD with or without asthma 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)
Hospital Length of Stay	3 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 30 days

Population: Overall, 80 eligible patients consented and were included.

Number of participants who were readmitted to the hospital within 30 days of study completion.

Outcome measures

Measure	COPD subjects n=80 Participants COPD with or without asthma 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)
Number of Participants With Readmissions	18 Participants

Adverse Events

COPD subjects

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure

COPD subjects n=80 participants at risk COPD with or without asthma 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)

Respiratory, thoracic and mediastinal disorders Hypoxic Ischemic Encephalopathy

1.2% 1/80 • Number of events 1 • Adverse Events (including serious adverse events) were monitored and reported from the time the participant was enrolled in the trial until they were discharged from the Hospital, up to 60 days. All Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours of awareness of the event. An AE will be considered serious if it meets any of the following criteria:

Other adverse events

Measure	COPD subjects n=80 participants at risk COPD with or without asthma 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)
Respiratory, thoracic and mediastinal disorders COPD / Asthma Exacerbation	5.0% 4/80 • Number of events 4 • Adverse Events (including serious adverse events) were monitored and reported from the time the participant was enrolled in the trial until they were discharged from the Hospital, up to 60 days. All Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours of awareness of the event. An AE will be considered serious if it meets any of the following criteria:
Gastrointestinal disorders Nausea	2.5% 2/80 • Number of events 2 • Adverse Events (including serious adverse events) were monitored and reported from the time the participant was enrolled in the trial until they were discharged from the Hospital, up to 60 days. All Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours of awareness of the event. An AE will be considered serious if it meets any of the following criteria:
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/80 • Number of events 1 • Adverse Events (including serious adverse events) were monitored and reported from the time the participant was enrolled in the trial until they were discharged from the Hospital, up to 60 days. All Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours of awareness of the event. An AE will be considered serious if it meets any of the following criteria:
Infections and infestations Pneumonia	6.2% 5/80 • Number of events 5 • Adverse Events (including serious adverse events) were monitored and reported from the time the participant was enrolled in the trial until they were discharged from the Hospital, up to 60 days. All Serious Adverse Events (SAEs) will be reported to the sponsor within 24 hours of awareness of the event. An AE will be considered serious if it meets any of the following criteria:

Additional Information

Clinical Research Manager

Baylor Scott & White Research Institute

Phone: 214-820-1771

Email: Felicia.Padilla@BSWHealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place