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Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients With Asthma (CPAP) (CPAP)

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ClinicalTrials.gov Identifier: NCT01629823
Recruitment Status : Completed
First Posted : June 28, 2012
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Intervention Device: Continuous Positive Airway Pressure device (Resmed, Swift, Mirage)
Enrollment 209
Recruitment Details  
Pre-assignment Details 209 individuals were enrolled in the study. 15 of those participants were excluded from data analysis due to significant data irregularities at one clinical site
Arm/Group Title CPAP Less Than 1 cm Water (H₂O) CPAP 5cm H₂O CPAP 10cm H₂O
Hide Arm/Group Description Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
Period Title: Trial Period
Started 66 69 59
Completed 53 56 49
Not Completed 13 13 10
Reason Not Completed
Missed visit             11             9             8
Pre-diluent FEV₁ predicted <70%             1             1             1
Pregnancy             1             0             0
Adverse Event             0             1             0
Out-of-window visit             0             2             0
Failed to hold medication             0             0             1
Period Title: Washout Period
Started 54 57 50
Completed 51 51 50
Not Completed 3 6 0
Reason Not Completed
Safety             2             5             0
Pregnancy             1             0             0
Protocol Violation             0             1             0
Arm/Group Title CPAP Less Than 1 cm H₂O CPAP 5cm H₂O CPAP 10cm H₂O Total
Hide Arm/Group Description Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization. Total of all reporting groups
Overall Number of Baseline Participants 66 69 59 194
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 66 participants 69 participants 59 participants 194 participants
33
(23 to 47)
31
(20 to 40)
25
(18 to 39)
31
(20 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 69 participants 59 participants 194 participants
Female
42
  63.6%
35
  50.7%
36
  61.0%
113
  58.2%
Male
24
  36.4%
34
  49.3%
23
  39.0%
81
  41.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 66 participants 69 participants 59 participants 194 participants
66 69 59 194
Asthma Symptom Utility Index (ASUI) Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 69 participants 59 participants 194 participants
0.89
(0.83 to 0.94)
0.94
(0.85 to 1.00)
0.92
(0.86 to 0.98)
0.92
(0.84 to 0.98)
[1]
Measure Description: The Asthma Symptom Utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. The minimum score is 0 and the maximum score is 1, with lower scores indicating more symptoms.
Asthma Control Test (ACT) Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 69 participants 59 participants 194 participants
21
(19 to 23)
22
(20 to 24)
22
(20 to 23)
22
(20 to 23)
[1]
Measure Description: The Asthma Control Test (ACT) is a validated self-administered survey utilizing 5 questions to assess asthma control on a scale from 1 (poor control) to 5 (total control) in individuals 12 years and older. By answering all 5 questions a patient with asthma can obtain a score that may range between 5 and 25. Asthma control is considered a good characteristic for a person with asthma and therefore a higher score is considered a better outcome.
Marks Asthma Quality of Life   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 69 participants 59 participants 194 participants
9
(5 to 21)
7
(3 to 11)
6
(3 to 10)
7
(4 to 12)
[1]
Measure Description: Marks Asthma Quality of Life Questionnaire (AQLQ) measures physical and emotional asthma specific quality of life during the past four weeks. The minimum score is 0 and the maximum score is 80, with lower scores indicating better quality of life. The scale is for use in adults only (individuals aged 18 or older).
Sinonasal Questionnaire (SNQ-6)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 69 participants 59 participants 194 participants
0.8
(0.6 to 1.6)
0.8
(0.4 to 1.4)
0.8
(0.4 to 1.2)
0.8
(0.4 to 1.4)
[1]
Measure Description: The Sinonasal Questionnaire (SNQ-6) is a six-item questionnaire designed to diagnose chronic sinonasal disease in patients with asthma. This questionnaire asks about runny nose, postnasal drip, need to blow the nose, facial pain or pressure, and nasal obstruction. Possible answers include never (zero points), 1-4 times per month (1 point), 2-6 times per week (2 points), and daily (3 points). The number of points is then averaged. The minimum score is 0 and the maximum score is 3, with higher scores indicating higher frequency of sinonasal disease symptoms.
PC20   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mg/mL
Number Analyzed 66 participants 69 participants 59 participants 194 participants
1.06
(0.47 to 2.95)
0.96
(0.30 to 2.66)
0.89
(0.28 to 2.33)
0.98
(0.33 to 2.74)
[1]
Measure Description: The PC20 is the concentration of methacholine needed to produce a 20% fall in forced expiratory volume in 1 second (FEV₁) from baseline.
FEV₁   [1] 
Median (Inter-Quartile Range)
Unit of measure:  L
Number Analyzed 66 participants 69 participants 59 participants 194 participants
2.9
(2.4 to 3.5)
3.1
(2.6 to 3.7)
3.0
(2.7 to 3.4)
3.1
(2.6 to 3.6)
[1]
Measure Description: FEV₁ stands for forced expiratory volume in one second, the volume that has been exhaled at the end of the first second of forced expiration.
Percent-predicted FEV₁  
Median (Inter-Quartile Range)
Unit of measure:  Percent
Number Analyzed 66 participants 69 participants 59 participants 194 participants
90.0
(84.0 to 96.3)
90.9
(81.9 to 99.9)
91.8
(80.7 to 98.0)
90.6
(82.7 to 97.9)
Forced vital capacity (FVC)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  L
Number Analyzed 66 participants 69 participants 59 participants 194 participants
3.9
(3.3 to 4.5)
4.2
(3.5 to 4.9)
3.9
(3.4 to 4.5)
4.1
(3.4 to 4.7)
[1]
Measure Description: Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort.
Daily use of inhaled corticosteroid (ICS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 69 participants 59 participants 194 participants
11 10 10 31
Daily use of combined inhaled corticosteroid/long acting beta agonist (ICS/LABA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 69 participants 59 participants 194 participants
18 23 13 54
Daily use of anti-leukotriene  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 69 participants 59 participants 194 participants
8 9 5 22
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 66 participants 69 participants 59 participants 194 participants
25.8
(23.0 to 29.8)
26.2
(22.3 to 28.9)
24.1
(22.0 to 28.8)
25.7
(22.3 to 29.0)
Former smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 69 participants 59 participants 194 participants
12 6 5 23
1.Primary Outcome
Title Methacholine Reactivity
Hide Description The primary outcome measure was the change in provocative concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (FEV₁) (PC20) from baseline to 12 weeks. Modified American Thoracic Society guidelines were followed for pre-bronchodilator spirometry and methacholine challenge testing using the 5 breath dosimeter technique. Up to eleven doses, each a doubling concentration of methacholine (Provocholine™), were inhaled starting at 0.03 mg/mL until a 20% or greater fall in FEV₁ occurred; the maximum dose was 32 mg/mL. Breaths each of doubling concentrations of methacholine were inhaled from a calibrated DeVilbiss™ 646 nebulizer.
Time Frame 12 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Less Than 1 cm H2O CPAP 5cm H2O CPAP 10cm H2O
Hide Arm/Group Description:
Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
Overall Number of Participants Analyzed 66 69 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/mL
PC20, 12-week
2.13
(1.30 to 3.49)
1.48
(0.96 to 2.28)
1.44
(0.91 to 2.27)
PC20, post-washout (14 weeks)
1.60
(0.96 to 2.69)
1.37
(0.91 to 2.07)
1.27
(0.81 to 2.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP Less Than 1 cm H2O, CPAP 5cm H2O
Comments Both the 5 and 10cm groups were compared to the control group, <1cm H₂O
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments Comparison of 5cm group to control. No adjustment for multiple comparisons.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.44 to 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CPAP Less Than 1 cm H2O, CPAP 10cm H2O
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.47 to 1.52
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPAP Less Than 1 cm H₂O CPAP 5cm H₂O CPAP 10cm H₂O
Hide Arm/Group Description Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization. Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
All-Cause Mortality
CPAP Less Than 1 cm H₂O CPAP 5cm H₂O CPAP 10cm H₂O
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
CPAP Less Than 1 cm H₂O CPAP 5cm H₂O CPAP 10cm H₂O
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/66 (1.52%)      1/69 (1.45%)      0/59 (0.00%)    
Blood and lymphatic system disorders       
Iron deficiency anemia [1]  0/66 (0.00%)  0 1/69 (1.45%)  1 0/59 (0.00%)  0
Nervous system disorders       
Ischemic stroke [2]  1/66 (1.52%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
Renal and urinary disorders       
Pyleonephritis [3]  1/66 (1.52%)  1 0/69 (0.00%)  0 0/59 (0.00%)  0
[1]
Hospitalization due to chronic blood loss and fatigue
[2]
Stroke
[3]
Kidney infection
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CPAP Less Than 1 cm H₂O CPAP 5cm H₂O CPAP 10cm H₂O
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/58 (58.62%)      35/62 (56.45%)      25/57 (43.86%)    
Ear and labyrinth disorders       
Ear or sinus discomfort  7/57 (12.28%)  7 8/60 (13.33%)  8 6/56 (10.71%)  6
Eye disorders       
Eye irritation  5/56 (8.93%)  5 4/61 (6.56%)  4 3/51 (5.88%)  3
General disorders       
Headache  15/50 (30.00%)  15 11/55 (20.00%)  11 14/46 (30.43%)  14
Drying of nose, mouth, and/or throat  10/55 (18.18%)  10 13/59 (22.03%)  13 8/55 (14.55%)  8
Nose irritation  6/57 (10.53%)  6 9/61 (14.75%)  9 7/56 (12.50%)  7
Congestion, runny nose, sneezing  21/52 (40.38%)  21 25/52 (48.08%)  25 14/46 (30.43%)  14
Respiratory, thoracic and mediastinal disorders       
Acute upper respiratory tract infection  9/58 (15.52%)  9 7/62 (11.29%)  7 5/57 (8.77%)  5
Social circumstances       
Increased work breathing  3/55 (5.45%)  3 7/60 (11.67%)  7 3/56 (5.36%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janet T Holbrook, PhD, MPH
Organization: ALA-ACRC
Phone: 443-287-3170
EMail: jholbro1@jhu.edu
Layout table for additonal information
Responsible Party: Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier: NCT01629823    
Other Study ID Numbers: ALA-ACRC-13
U01HL108730 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2012
First Posted: June 28, 2012
Results First Submitted: January 30, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017