Effect of Whole Body Periodic Acceleration on Airway Endothelial Function

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213706
• Other study ID #: 20090748
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: September 5, 2014
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: September 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Healthy Control
• Smokers

Intervention

Device:
• Whole Body Periodic Acceleration (WBPA)
Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
• Sham WBPA
The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.

Locations

Country	Name	City	State
United States	Pulmonary Human Research Laboratory, University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No