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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: CPAP-Continuous Positive Airway Pressure Device: SHAM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Assessment of the Effects of Short and Long Term Use of Continuous Positive Airway Pressure on Airway Reactivity in Children and Adults With and Without Asthma|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Subjects will use CPAP of 8-12 during days 2 through 6 of the study.
Device: CPAP-Continuous Positive Airway Pressure
Cpap will be worn at night by subjects 6 to 7 days duration.
Sham Comparator: SHAM
Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.
SHAM will be worn at night by subjects 6 to 7 days duration.
- Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 7 to 10 nights after cpap is started. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592631
|United States, Indiana|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Robert S. Tepper, MD, PhD||Indiana University|
|Study Director:||Mike Busk, MD||NIFS/ Indiana University|