Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asthmatics

Conditions
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Healthy, Smokers, Asthma

Intervention / Treatment
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* Device: Whole Body Periodic Acceleration (WBPA)
* Device: Sham WBPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 healthy never-smokers, 15 smokers (> than 1 year smoke history) and 15 never-smokers asthmatics; FEV1 > 80% (except for asthmatics 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 asthmatics; FEV1 < 80% on the screening day (excepted for asthmatics subjets)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Body Periodic Acceleration (WBPA)<br>All subjects will be performing this procedure. 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. | Device: Whole Body Periodic Acceleration (WBPA)<br>* Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.<br>Device: Sham WBPA<br>* The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.<br>|
| Experimental: Sham WBPA<br>Sham WBPA : All subjects will be performing this procedure before the WBPA. The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge. | Device: Whole Body Periodic Acceleration (WBPA)<br>* Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.<br>Device: Sham WBPA<br>* The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Blood Flow Response to Albuterol | Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation. | Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway blood flow, albuterol, Whole Body Periodic Acceleration (WBPA), Nitric Oxide, Endothelial Dysfunction