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