Clinical trial NCT01213706: Effect of Whole Body Periodic Acceleration on Airway Endothelial Function
Official title: Effect of Whole Body Periodic Acceleration on Airway Endothelial Function in Healthy Smokers, Non-smokers and Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Smokers
Asthma
Keywords: airway blood flow
albuterol
Whole Body Periodic Acceleration (WBPA)
Nitric Oxide
Endothelial Dysfunction
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 criteria: 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)

Primary outcomes:
measure: Airway Blood Flow Response to Albuterol
timeFrame: Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Adam Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sackner MA, Gummels E, Adams JA. Nitric oxide is released into circulation with whole-body, periodic acceleration. Chest. 2005 Jan;127(1):30-9. doi: 10.1378/chest.127.1.30.
citation: Sackner MA, Gummels E, Adams JA. Effect of moderate-intensity exercise, whole-body periodic acceleration, and passive cycling on nitric oxide release into circulation. Chest. 2005 Oct;128(4):2794-803. doi: 10.1378/chest.128.4.2794.
citation: Matsumoto T, Fujita M, Tarutani Y, Yamane T, Takashima H, Nakae I, Horie M. Whole-body periodic acceleration enhances brachial endothelial function. Circ J. 2008 Jan;72(1):139-43. doi: 10.1253/circj.72.139.