Trial Outcomes & Findings for Modulation Of Airway Reactivity With Chronic Mechanical Strain (NCT NCT02396849)
NCT ID: NCT02396849
Last Updated: 2021-03-09
Results Overview
The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment. Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 μL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.
COMPLETED
NA
84 participants
baseline (visit 1) and 4 weeks (visit 2)
2021-03-09
Participant Flow
25 were excluded based on screening criteria, two subjects (one in each group) were lost to follow-up, two (one in each group) did not tolerate the equipment and two (one in each group) did not undergo Methacholine challenge at V2 due to the presence of asthma symptoms.
Participant milestones
| Measure |
Continuous Positive Airway Pressure (CPAP)
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
Continuous Positive Airway Pressure (CPAP) Sham
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Continuous Positive Airway Pressure (CPAP)
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
Continuous Positive Airway Pressure (CPAP) Sham
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Did not tolerate intervention
|
1
|
1
|
Baseline Characteristics
Modulation Of Airway Reactivity With Chronic Mechanical Strain
Baseline characteristics by cohort
| Measure |
CPAP
n=27 Participants
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
CPAP Sham
n=28 Participants
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
11.7 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
11.5 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 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
|
1 Participants
n=7 Participants
|
1 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
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Methacholine Bronchial Challenge
|
2.9 mg/mL
STANDARD_DEVIATION 4.5 • n=5 Participants
|
3.2 mg/mL
STANDARD_DEVIATION 4.3 • n=7 Participants
|
3.09 mg/mL
STANDARD_DEVIATION 4.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (visit 1) and 4 weeks (visit 2)Population: One subject in each group did not undergo Methacholine challenge at V2 due to the presence of asthma symptoms
The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment. Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 μL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.
Outcome measures
| Measure |
CPAP
n=26 Participants
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
CPAP Sham
n=27 Participants
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|---|---|---|
|
Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
Visit 1
|
3.0 mg/mL
Standard Deviation 4.6
|
3.2 mg/mL
Standard Deviation 4.4
|
|
Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
Visit 2
|
5.3 mg/mL
Standard Deviation 8.9
|
4.3 mg/mL
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: baseline (visit 1) and 4 weeks (visit 2)Population: The overall success rate in obtaining quality sputum samples was 57%; however, only 10 CPAP and 12 sham subjects had quality samples at both study visits.
Airway Inflammation assessed as the change in the percentage eosinophils in the induced sputum measured prior to and after 4 weeks of Continuous Positive Airway Pressure (CPAP) or sham CPAP treatment.
Outcome measures
| Measure |
CPAP
n=10 Participants
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
CPAP Sham
n=12 Participants
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|---|---|---|
|
Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
Study Visit 1
|
6.2 Percentage of sputum eosinophils
Standard Deviation 10.1
|
3.9 Percentage of sputum eosinophils
Standard Deviation 5.0
|
|
Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
Study Visit 2
|
3.6 Percentage of sputum eosinophils
Standard Deviation 6.4
|
5.4 Percentage of sputum eosinophils
Standard Deviation 8.2
|
Adverse Events
CPAP
CPAP Sham
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPAP
n=29 participants at risk
Use of a CPAP machine for at least 5 days per week for 28 days
CPAP: Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
CPAP Sham
n=30 participants at risk
Use of a sham CPAP machine for at least 5 days per week for 28 days
CPAP Sham: Subjects assigned to this group will be asked to use the CPAP SHAM machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation treated with oral corticosteroids
|
17.2%
5/29 • 4 weeks
Adverse event were described as an asthma exacerbation requiring oral corticosteroids during the study period.
|
10.0%
3/30 • 4 weeks
Adverse event were described as an asthma exacerbation requiring oral corticosteroids during the study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place