Asthma, Healthy, Smokers
Conditions
Keywords
airway blood flow, albuterol, Whole Body Periodic Acceleration (WBPA), Nitric Oxide, Endothelial Dysfunction
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.
Interventions
DEVICEWhole Body Periodic Acceleration (WBPA)
Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
DEVICESham WBPA
The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway Blood Flow Response to Albuterol | Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA | Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Whole Body Periodic Acceleration (WBPA) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Airway Blood Flow Response to Albuterol
Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.
Time frame: Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA
Population: controls n =15, smokers N=15 , asthma N=15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WBPA | Airway Blood Flow Response to Albuterol | Asthma N=15,15 | 1.96 μl/min/ml | Standard Error 2.06 |
| WBPA | Airway Blood Flow Response to Albuterol | Smokers n=15,15 | 2.85 μl/min/ml | Standard Error 2.33 |
| WBPA | Airway Blood Flow Response to Albuterol | Controls N=15, 15 | 17.93 μl/min/ml | Standard Error 2.08 |
| Sham WBPA | Airway Blood Flow Response to Albuterol | Controls N=15, 15 | 4.03 μl/min/ml | Standard Error 0.8 |
| Sham WBPA | Airway Blood Flow Response to Albuterol | Smokers n=15,15 | -1.43 μl/min/ml | Standard Error 2.8 |
| Sham WBPA | Airway Blood Flow Response to Albuterol | Asthma N=15,15 | 1.65 μl/min/ml | Standard Error 0.8 |