Trial Outcomes & Findings for Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD (NCT NCT03935932)
NCT ID: NCT03935932
Last Updated: 2023-06-08
Results Overview
Percentage of radioactivity cleared from the right lung
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
0-4 hours
Results posted on
2023-06-08
Participant Flow
Participant milestones
| Measure |
Baseline Followed by Intervention
Subjects randomized to perform baseline measurement of clearance on study day 2 and measurement of clearance with nasal delivery of heated and humidified air on day 3. Study days are separated by 4-7 days
nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula for four hours
|
Intervention Followed by Baseline
Subjects randomized to perform measurement of clearance with nasal delivery of heated and humidified air on day 2 and baseline measurement of clearance on study day 3. Study days are separated by 4-7 days.
nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula for 4 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Humidified Air to Improve Mucociliary Clearance (MCC) in COPD
Baseline characteristics by cohort
| Measure |
Baseline Followed by Intervention
n=6 Participants
Subjects randomized to perform baseline measurement of clearance on study day 2 and measurement of clearance with nasal delivery of heated and humidified air on day 3
nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Intervention Followed by Baseline
n=6 Participants
Subjects randomized to perform measurement of clearance with nasal delivery of heated and humidified air on day 2 and baseline measurement of clearance on study day 3
nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
70 years
n=7 Participants
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-4 hoursPercentage of radioactivity cleared from the right lung
Outcome measures
| Measure |
AIRVO Day
n=12 Participants
Nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Baseline Day
n=12 Participants
Baseline assessment of mucociliary clearance
|
|---|---|---|
|
Mucociliary Clearance Rate - 4 Hours
|
47 percent clearance
Interval 23.0 to 66.0
|
56 percent clearance
Interval 40.0 to 68.0
|
SECONDARY outcome
Timeframe: 0-90 minutesPercentage of radioactivity cleared from the right lung
Outcome measures
| Measure |
AIRVO Day
n=12 Participants
Nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Baseline Day
n=12 Participants
Baseline assessment of mucociliary clearance
|
|---|---|---|
|
Mucociliary Clearance Rate - 90 Min
|
22 percent clearance
Interval 14.0 to 31.0
|
34 percent clearance
Interval 17.0 to 47.0
|
SECONDARY outcome
Timeframe: 0-90 minutesArea above the curve of normalized retention of radioactivity vs time from the right lung
Outcome measures
| Measure |
AIRVO Day
n=12 Participants
Nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Baseline Day
n=12 Participants
Baseline assessment of mucociliary clearance
|
|---|---|---|
|
Area Above Retention Curve - 90 Min
|
6.2 percent clearance x time (minutes)
Interval 2.3 to 8.8
|
8.0 percent clearance x time (minutes)
Interval 1.4 to 11.9
|
Adverse Events
Airvo Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Baseline Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Airvo Day
n=12 participants at risk
Nasal delivery of heated and humidified air: Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
|
Baseline Day
n=12 participants at risk
Baseline measure of mucociliary clearance
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
flank pain
|
8.3%
1/12 • Number of events 1 • study days only, up to14 days
|
0.00%
0/12 • study days only, up to14 days
|
|
Respiratory, thoracic and mediastinal disorders
burning sensation in chest
|
8.3%
1/12 • Number of events 1 • study days only, up to14 days
|
0.00%
0/12 • study days only, up to14 days
|
Additional Information
Tim Corcoran, Associate Professor
University of Pittsburgh
Phone: 4126922210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place