Trial Outcomes & Findings for HFNC Effect on BCSS in Patients With COPD (NCT NCT02825043)

NCT ID: NCT02825043

Last Updated: 2020-06-29

Results Overview

The Changes in Breathlessness, Cough and Sputum Scale (BCSS) is a three question measure consisting of three questions, each rated on a scale of "0" to "4", with a total possible score ranging from 0-12. Zero equals no difficulty and four equals severe difficulty or constant problem. A lower score on the scale is a better outcome.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-06-29

Participant Flow

Participant milestones

Measure	High Flow Nasal Cannula Participants High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study. High-Flow Nasal Cannula: This is a humidified oxygen delivery system.
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	High Flow Nasal Cannula Participants High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study. High-Flow Nasal Cannula: This is a humidified oxygen delivery system.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High Flow Nasal Cannula Participants n=6 Participants High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study. High-Flow Nasal Cannula: This is a humidified oxygen delivery system.
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants
Sex/Gender, Customized Sex Not Collected	6 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Four (4) participants were lost to follow-up and no data was collected. Two (2) participants returned BCSS scores at which time, baseline data was not collected due to decision to terminate study. Baseline data is required to calculate change in BCSS.

The Changes in Breathlessness, Cough and Sputum Scale (BCSS) is a three question measure consisting of three questions, each rated on a scale of "0" to "4", with a total possible score ranging from 0-12. Zero equals no difficulty and four equals severe difficulty or constant problem. A lower score on the scale is a better outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Four (4) participants were lost to follow-up and no data was collected on those participants. Data was not collected on remaining two (2) participants for this outcome measure.

The number of chronic obstructive pulmonary disease exacerbations per month will be monitored throughout the study. A lower number of chronic obstructive pulmonary disease exacerbations are considered improvement.

Outcome measures

Outcome data not reported

Adverse Events

High Flow Nasal Cannula Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Flow Nasal Cannula Participants n=5 participants at risk High Flow Nasal Cannula Participants will be their own control, they will be in study for 3 months prior to receiving equipment and then will be studied for 3 additional months on study. High-Flow Nasal Cannula: This is a humidified oxygen delivery system.
Product Issues Condensation in tubing	20.0% 1/5 • Number of events 1 • 7 months

Additional Information

Clinical Trials Manager

University of Oklahoma Health Sciences Center Dept. of Medicine

Phone: (405)271-6651

Email: research@ouhsc.edu

Results disclosure agreements

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