Effect of Whole Body Periodic Acceleration on Airway Endothelial Function
Recruitment status was Recruiting
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Purpose
In the present proposal the investigators wish to assess the effect of a single session with the device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) on baseline airway blood flow (Qaw) and in Qaw variation, in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation that the treatment will transiently increase the Qaw, and to a greater extent in the current smokers and patients with asthma who have endothelial dysfunction.
| Condition | Intervention |
|---|---|
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Healthy Control Smokers Asthma |
Device: Whole Body Periodic Acceleration (WBPA) Device: Sham WBPA |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asmathics |
- Airway Blood Flow changes [ Time Frame: Qaw post minus Qaw pre WBPA treatment ] [ Designated as safety issue: No ]
- Qaw baseline
- WBPA control time (45 minutes on rest)
- Qaw immediately after rest
- FEV1 pre WBPA treatment
- Qaw 15 minutes after rest (albuterol control time)
- WBPA treatment (45 minutes)
- Qaw immediately after WBPA treatment
- Albuterol administration (180µg)
- Qaw 15 minutes after albuterol aministration
- FEV1 post treatment
- Nitric Oxide (NO) variation [ Time Frame: NO post minus NO pre WBPA treatment ] [ Designated as safety issue: No ]Collect venous blood sample (5ml) for NO measurement pre WBPA treatment and collect again venous blood sample (5ml) for NO measurement post WBPA treatment.
| Estimated Enrollment: | 55 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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Active Comparator: Whole Body Periodic Acceleration (WBPA)
Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.
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Device: Whole Body Periodic Acceleration (WBPA)
Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
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Sham Comparator: Sham WBPA
The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
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Device: Sham WBPA
The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
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Detailed Description:
Endothelial shear stress activates nitric oxide synthase (NOS), leading to endothelium-dependent vasodilation. This can be accomplished through exercise or with a device known as Exer-Rest® which applies Whole Body Periodic Acceleration (WBPA) that is also called pGz. WBPA produces systemic vasodilation, by exerting shear stress on the vascular endothelium, activating endothelial NOS and releasing NO in animal models and human subjects. Cigarette smoking is associated with attenuated vascular relaxation responses in the systemic circulation. Patients with asthma also exhibit endothelial dysfunction in the airway. In this study the investigators wish to assess the effect of a single pGz session on baseline Qaw and delta Qaw in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers to test if this treatment will increase the vascular relaxation responses.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Adam Wanner, MD | (305) 243-2568 | awanner@miami.edu |
| Contact: Eliana Mendes, MD | (305) 243-2568 | emendes@med.miami.edu |
| United States, Florida | |
| Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Adam Wanner, MD 305-243-2568 awanner@miami.edu | |
| Contact: Eliana Mendes, MD (305) 243-2568 emendes@med.miami.edu | |
| Principal Investigator: Adam Wanner, MD | |
| Principal Investigator: | Adam Wanner, MD | University of Miami |
More Information
Publications:
| Responsible Party: | Adam Wanner, University of Miami, Miller School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01213706 History of Changes |
| Other Study ID Numbers: | 20090748 |
| Study First Received: | October 1, 2010 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Miami:
|
airway blood flow albuterol Whole Body Periodic Acceleration (WBPA) Nitric Oxide Endothelial Dysfunction |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013