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Assessment Of The Effects Of Short and Long Term Use Of CPAP

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ClinicalTrials.gov Identifier: NCT00592631
Recruitment Status : Terminated (Key investigator resigned)
First Posted : January 14, 2008
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Asthma
Interventions Device: CPAP-Continuous Positive Airway Pressure
Device: SHAM
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Continuous Positivie Airway Pressure Sham Treatment
Hide Arm/Group Description Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment. Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
Period Title: Overall Study
Started 16 11
Completed 16 9
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
Arm/Group Title CPAP Sham Total
Hide Arm/Group Description Subjects used CPAP set at 8-10 cmH20 for 7-10 nights. Subjects used SHAM set at 0-2 cmH20 for 7-10 nights Total of all reporting groups
Overall Number of Baseline Participants 16 9 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 9 participants 25 participants
27  (6) 32  (9) 29  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 9 participants 25 participants
Female
11
  68.8%
6
  66.7%
17
  68.0%
Male
5
  31.3%
3
  33.3%
8
  32.0%
1.Primary Outcome
Title Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.
Time Frame 7 to 10 nights after cpap is started.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Sham
Hide Arm/Group Description:
Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
Subjects used sham set at 0-2 cmH20 for 7-10 nights
Overall Number of Participants Analyzed 16 9
Mean (Standard Error)
Unit of Measure: log mg/ml
0.406  (0.066) 0.003  (0.193)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Continuous Positive Airway Pressure Sham
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Continuous Positive Airway Pressure Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Continuous Positive Airway Pressure Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Continuous Positive Airway Pressure Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/9 (0.00%) 
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: Robert Tepper, MD, Ph.D.
Organization: Indiana University
Phone: 317-274-9647
EMail: rtepper@iu.edu
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00592631    
Other Study ID Numbers: 0405-16
0405-16
First Submitted: January 2, 2008
First Posted: January 14, 2008
Results First Submitted: November 12, 2015
Results First Posted: February 10, 2016
Last Update Posted: February 10, 2016