|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01213706 |
|
Date of registration:
|
01/10/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Whole Body Periodic Acceleration on Airway Endothelial Function
|
|
Scientific title:
|
Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asmathics |
|
Date of first enrolment:
|
October 2009 |
|
Target sample size:
|
55 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01213706 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Adam Wanner, MD |
|
Address:
|
|
|
Telephone:
|
305-243-2568 |
|
Email:
|
awanner@miami.edu |
|
Affiliation:
|
|
|
|
Name:
|
Adam Wanner, MD |
|
Address:
|
|
|
Telephone:
|
(305) 243-2568 |
|
Email:
|
awanner@miami.edu |
|
Affiliation:
|
|
|
|
Name:
|
Adam Wanner, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Miami |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
15 healthy never-smokers, 15 smokers (> than 1 year smoke history) and 15 never-smokers asmathics; FEV1 > 80% (except for asmathics subjets)
Exclusion Criteria:
Women of childbearing potential who do not accepted birth control measures; pregnant and breast feeding; cardiovascular disease or use of cardiovascular drugs; respiratory infection during the 4 weeks preceding the study; use of inhaled or systemic glucocorticoids, leukotriene modifiers or theophyllines in asmathics; FEV1 < 80% on the screening day (excepted for asmathics subjets)
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Asthma
|
|
Healthy Control
|
|
Smokers
|
|
Intervention(s)
|
|
Device: Sham WBPA
|
|
Device: Whole Body Periodic Acceleration (WBPA)
|
|
Primary Outcome(s)
|
|
Airway Blood Flow changes
[Time Frame: Qaw post minus Qaw pre WBPA treatment]
|
|
Secondary Outcome(s)
|
|
Nitric Oxide (NO) variation
[Time Frame: NO post minus NO pre WBPA treatment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|