Trial Outcomes & Findings for Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis (NCT NCT02129803)
NCT ID: NCT02129803
Last Updated: 2021-01-06
Results Overview
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Day 0 to Day 6 or upon discharge from the hospital, whichever comes first
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
Experimental Therapy
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
|
Control Therapy (Low Flow)
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Experimental Therapy
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
|
Control Therapy (Low Flow)
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Difficulty sleeping
|
1
|
0
|
|
Overall Study
Morning headache
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Experimental Therapy
n=12 Participants
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
|
Control Therapy (Low Flow)
n=12 Participants
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Age, Continuous
|
19.4 years
STANDARD_DEVIATION 5.4 • n=99 Participants
|
21.7 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
20.5 years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 6 or upon discharge from the hospital, whichever comes firstPopulation: Results could not be reported for 4 participants due to missing baseline data in one case, missing followup data in one case, and no CFQ-R data in two cases.
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.
Outcome measures
| Measure |
Experimental Therapy
n=3 Participants
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
|
Control Therapy (Low Flow)
n=8 Participants
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.
|
|---|---|---|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Physical functioning subscale
|
0.056 change in score on a scale
Standard Deviation 0.105
|
0.052 change in score on a scale
Standard Deviation 0.152
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Vitality subscale
|
0.192 change in score on a scale
Standard Deviation 0.139
|
0.194 change in score on a scale
Standard Deviation 0.115
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Emotional state subscale
|
-0.089 change in score on a scale
Standard Deviation 0.139
|
0.033 change in score on a scale
Standard Deviation 0.087
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Social limitations subscale
|
-0.056 change in score on a scale
Standard Deviation 0.096
|
-0.028 change in score on a scale
Standard Deviation 0.154
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Role limitations subscale
|
-0.056 change in score on a scale
Standard Deviation 0.192
|
0.010 change in score on a scale
Standard Deviation 0.175
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Body image subscale
|
0.037 change in score on a scale
Standard Deviation 0.170
|
0.125 change in score on a scale
Standard Deviation 0.192
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Eating disturbances subscale
|
0.037 change in score on a scale
Standard Deviation 0.280
|
0.097 change in score on a scale
Standard Deviation 0.162
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Treatment constraints subscale
|
-0.037 change in score on a scale
Standard Deviation 0.170
|
-0.097 change in score on a scale
Standard Deviation 0.093
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Respiratory symptoms subscale
|
0.019 change in score on a scale
Standard Deviation 0.170
|
-0.125 change in score on a scale
Standard Deviation 0.856
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Digestive symptoms subscale
|
0.111 change in score on a scale
Standard Deviation 0.192
|
0.028 change in score on a scale
Standard Deviation 0.098
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Weight subscale
|
-0.222 change in score on a scale
Standard Deviation 0.192
|
0.083 change in score on a scale
Standard Deviation 0.236
|
|
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Health status subscale
|
-0.083 change in score on a scale
Standard Deviation 0.399
|
0.000 change in score on a scale
Standard Deviation 0.103
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: We were unable to collect sputum samples from the participants
Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Therapy (Low Flow)
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 |
Experimental Therapy
n=6 participants at risk
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
High-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
|
Control Therapy (Low Flow)
n=9 participants at risk
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
Low FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.
|
|---|---|---|
|
Product Issues
Nasal discomfort
|
33.3%
2/6 • Number of events 2 • Length of hospital stay - up to 3 months
|
11.1%
1/9 • Number of events 1 • Length of hospital stay - up to 3 months
|
Additional Information
Bruce K. Rubin MEngr, MD, MBA, FRCPC
Virginia Commonwealth University
Phone: 804 828 9604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place