Trial Outcomes & Findings for Positive Airway Pressure for the Treatment of Asthma (NCT NCT01154699)
NCT ID: NCT01154699
Last Updated: 2017-05-17
Results Overview
Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).
COMPLETED
NA
31 participants
Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)
2017-05-17
Participant Flow
33 subjects were assessed for eligibility (20 asthma only, 13 asthma + OSA). 12 were excluded, with 11 not meeting inclusion criteria, and 1 declining to participate.
Participant milestones
| Measure |
Usual Care First, Then Bilevel PAP
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a "Washout Period" of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
Bilevel PAP First, Then Usual Care
Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week "Washout Period" of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
13
|
8
|
|
First Intervention (4 Weeks)
Subjects With Asthma Only
|
7
|
6
|
|
First Intervention (4 Weeks)
Subjects With Asthma + OSA
|
6
|
2
|
|
First Intervention (4 Weeks)
COMPLETED
|
13
|
8
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (4 Weeks)
STARTED
|
13
|
8
|
|
Washout Period (4 Weeks)
Subjects With Asthma Only
|
7
|
6
|
|
Washout Period (4 Weeks)
Subjects With Asthma + OSA
|
6
|
2
|
|
Washout Period (4 Weeks)
COMPLETED
|
13
|
8
|
|
Washout Period (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
13
|
8
|
|
Second Intervention
Subjects With Asthma Only
|
7
|
6
|
|
Second Intervention
Subjects With Asthma + OSA
|
6
|
2
|
|
Second Intervention
COMPLETED
|
13
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects with ASTHMA only do not use CPAP
Baseline characteristics by cohort
| Measure |
Asthma Only
n=13 Participants
Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
|
Asthma + OSA
n=8 Participants
Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 16.7 • n=13 Participants
|
44.75 years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
43.8 years
STANDARD_DEVIATION 14.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=13 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=13 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
8 participants
n=8 Participants
|
21 participants
n=21 Participants
|
|
Body Mass Index (kg/m2)
|
30.5 kg/m2
STANDARD_DEVIATION 7.4 • n=13 Participants
|
36.4 kg/m2
STANDARD_DEVIATION 5.2 • n=8 Participants
|
32.7 kg/m2
STANDARD_DEVIATION 7.2 • n=21 Participants
|
|
FEV1% predicted
|
90.2 %
STANDARD_DEVIATION 21.3 • n=13 Participants
|
89.4 %
STANDARD_DEVIATION 21.0 • n=8 Participants
|
89.9 %
STANDARD_DEVIATION 20.7 • n=21 Participants
|
|
FEV1/FVC
|
0.75 ratio
STANDARD_DEVIATION 0.09 • n=13 Participants
|
0.75 ratio
STANDARD_DEVIATION .06 • n=8 Participants
|
0.75 ratio
STANDARD_DEVIATION .07 • n=21 Participants
|
|
PC20 (mg/mL)
|
1.5 mg/mL
STANDARD_DEVIATION 0.5 • n=13 Participants
|
1.8 mg/mL
STANDARD_DEVIATION 1.4 • n=8 Participants
|
1.6 mg/mL
STANDARD_DEVIATION 0.3 • n=21 Participants
|
|
AHI (events/hour)
|
2.5 events per hour
STANDARD_DEVIATION 2.3 • n=13 Participants
|
40.0 events per hour
STANDARD_DEVIATION 30.1 • n=8 Participants
|
11.6 events per hour
STANDARD_DEVIATION 3.4 • n=21 Participants
|
|
CPAP Pressure
|
—
|
11.6 cm of water
STANDARD_DEVIATION 3.4 • n=8 Participants • Subjects with ASTHMA only do not use CPAP
|
11.6 cm of water
STANDARD_DEVIATION 3.4 • n=8 Participants • Subjects with ASTHMA only do not use CPAP
|
|
CPAP Usage
|
—
|
264 minutes
STANDARD_DEVIATION 96 • n=8 Participants • Subjects with asthma ONLY do not use CPAP
|
264 minutes
STANDARD_DEVIATION 96 • n=8 Participants • Subjects with asthma ONLY do not use CPAP
|
PRIMARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)Population: All 21 patients went through usual care and bilevel PAP therapy
Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
Asthma Control Test
Pre
|
19.3 units on a scale
Standard Deviation 5.1
|
19.8 units on a scale
Standard Deviation 3.4
|
|
Asthma Control Test
Post
|
19.1 units on a scale
Standard Deviation 4.6
|
19.6 units on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)Population: All subjects completed the crossover study design
This is a physiological measurement derived from repeated breathing maneuvers which measures airway reactivity. Subjects are exposed to higher and higher concentrations of an airway irritant (in this case methacholine), and between each dose perform spirometry. The test is stopped after the forced expiratory volume in 1 second (FEV1) falls 20% below the baseline. The concentration of methacholine at which this occurs is called the PC20. Methacholine challenges are routinely used in the diagnosis of asthma, and in many asthma research studies to measure changes in airway reactivity.
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
Airway Reactivity as Measured by Methacholine Challenge (PC20)
Pre
|
1.3 mg/mL
Standard Error 0.31
|
1.24 mg/mL
Standard Error 1.97
|
|
Airway Reactivity as Measured by Methacholine Challenge (PC20)
Post
|
0.88 mg/mL
Standard Error 2.41
|
1.36 mg/mL
Standard Error 2.13
|
SECONDARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)Population: All subjects completed both arms of this crossover study.
8 item questionnaire to measure daytime sleepiness, with total score reported 0 (less sleepy) to 24 (most sleepy). Scores greater than or equal to 10 are considered excessive daytime sleepiness.
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
Pre
|
9.1 units on a scale
Standard Deviation 5.4
|
9.8 units on a scale
Standard Deviation 5.0
|
|
Epworth Sleepiness Scale (ESS)
Post
|
9.7 units on a scale
Standard Deviation 4.6
|
9.1 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)Population: All subjects completed both arms of this crossover study.
Well validated questionnaire used frequently to measure sleep quality over the prior 1 month. It consists of 19 individual items that combine to form 7 components summed to create one global score. The overall score is between 0 (better sleep) and 21 (worse sleep).
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
pre
|
6.8 units on a scale
Standard Deviation 4.0
|
6.6 units on a scale
Standard Deviation 3.3
|
|
Pittsburgh Sleep Quality Index (PSQI)
post
|
6.1 units on a scale
Standard Deviation 3.4
|
6.1 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)Population: All subjects completed both arms of the study
Well validated quality of life questionnaire that measures eight sub-sections, which are summed to yield a score from 0 (maximal disability) to 100 (no disability). The eight subsections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
Short Form (SF-36) Health Survey
pre
|
70.8 units on a scale
Standard Deviation 15.4
|
74.0 units on a scale
Standard Deviation 14.5
|
|
Short Form (SF-36) Health Survey
post
|
70.3 units on a scale
Standard Deviation 16.8
|
73.5 units on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)Population: All subjects completed both arms of this crossover study.
Performed as part of spirometry
Outcome measures
| Measure |
Usual Care
n=21 Participants
Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
|
Bilevel PAP
n=21 Participants
Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
|
|---|---|---|
|
FEV1 %Predicted
pre
|
89.9 percentage of predicted FEV1
Standard Deviation 20.7
|
87.1 percentage of predicted FEV1
Standard Deviation 22.4
|
|
FEV1 %Predicted
post
|
88.1 percentage of predicted FEV1
Standard Deviation 22.3
|
89.7 percentage of predicted FEV1
Standard Deviation 20.0
|
Adverse Events
Asthma Only
Asthma + OSA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asthma Only
n=13 participants at risk
Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
|
Asthma + OSA
n=8 participants at risk
Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Central Sleep Apnea
|
23.1%
3/13 • Number of events 3
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place