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Positive Airway Pressure for the Treatment of Asthma

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert L. Owens, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01154699
First received: June 18, 2010
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: January 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Asthma
Sleep Apnea
Interventions: Device: Bilevel PAP (4 weeks)
Other: Usual Care (4 weeks)
Other: Washout Period (4 weeks)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
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.

Participant Flow for 3 periods

Period 1:   First Intervention (4 Weeks)
    Usual Care First, Then Bilevel PAP   Bilevel PAP First, Then Usual Care
STARTED   13   8 
Subjects With Asthma Only [1]   7   6 
Subjects With Asthma + OSA [2]   6   2 
COMPLETED   13   8 
NOT COMPLETED   0   0 
[1] The number of subjects who had asthma but NOT OSA in each arm
[2] The number of subjects who had asthma and OSA in each arm

Period 2:   Washout Period (4 Weeks)
    Usual Care First, Then Bilevel PAP   Bilevel PAP First, Then Usual Care
STARTED   13   8 
Subjects With Asthma Only   7   6 
Subjects With Asthma + OSA   6   2 
COMPLETED   13   8 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Usual Care First, Then Bilevel PAP   Bilevel PAP First, Then Usual Care
STARTED   13   8 
Subjects With Asthma Only   7   6 
Subjects With Asthma + OSA   6   2 
COMPLETED   13   8 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Asthma Only Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
Asthma + OSA Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
Total Total of all reporting groups

Baseline Measures
   Asthma Only   Asthma + OSA   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   8   21 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   43.2  (16.7)   44.75  (10.5)   43.8  (14.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
Female      9  69.2%      5  62.5%      14  66.7% 
Male      4  30.8%      3  37.5%      7  33.3% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 13   8   21 
United States   13   8   21 
Body Mass Index (kg/m2) 
[Units: Kg/m2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   30.5  (7.4)   36.4  (5.2)   32.7  (7.2) 
FEV1% predicted 
[Units: %]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   90.2  (21.3)   89.4  (21.0)   89.9  (20.7) 
FEV1/FVC 
[Units: Ratio]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   0.75  (0.09)   0.75  (.06)   0.75  (.07) 
PC20 (mg/mL) 
[Units: mg/mL]
Geometric Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   1.5  (0.5)   1.8  (1.4)   1.6  (0.3) 
AHI (events/hour) 
[Units: Events per hour]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 13   8   21 
   2.5  (2.3)   40.0  (30.1)   11.6  (3.4) 
CPAP Pressure [1] 
[Units: Cm of water]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 0   8   8 
      11.6  (3.4)   11.6  (3.4) 
[1] Subjects with ASTHMA only do not use CPAP
CPAP Usage [1] 
[Units: Minutes]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 0   8   8 
      264  (96)   264  (96) 
[1] Subjects with asthma ONLY do not use CPAP


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Asthma Control Test   [ Time Frame: 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) ]

2.  Primary:   Airway Reactivity as Measured by Methacholine Challenge (PC20)   [ Time Frame: 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) ]

3.  Secondary:   Epworth Sleepiness Scale (ESS)   [ Time Frame: 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) ]

4.  Secondary:   Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: 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) ]

5.  Secondary:   Short Form (SF-36) Health Survey   [ Time Frame: 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) ]

6.  Secondary:   FEV1 %Predicted   [ Time Frame: 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Robert L. Owens
Organization: University of California San Diego
phone: 8586575258
e-mail: rowens@ucsd.edu



Responsible Party: Robert L. Owens, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01154699     History of Changes
Other Study ID Numbers: 2009-P-001733/1
1F32HL097578-01 ( U.S. NIH Grant/Contract )
5K23HL105542 ( U.S. NIH Grant/Contract )
Study First Received: June 18, 2010
Results First Received: January 13, 2017
Last Updated: May 11, 2017