Trial Outcomes & Findings for Effect of Whole Body Periodic Acceleration on Airway Endothelial Function (NCT NCT01213706)
NCT ID: NCT01213706
Last Updated: 2016-08-10
Results Overview
Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA
Results posted on
2016-08-10
Participant Flow
Participant milestones
| Measure |
SHAM WBPA Then WBPA
|
|---|---|
|
Sham WBPA
STARTED
|
45
|
|
Sham WBPA
COMPLETED
|
45
|
|
Sham WBPA
NOT COMPLETED
|
0
|
|
Washout (1 Hour)
STARTED
|
45
|
|
Washout (1 Hour)
COMPLETED
|
45
|
|
Washout (1 Hour)
NOT COMPLETED
|
0
|
|
WBPA
STARTED
|
45
|
|
WBPA
COMPLETED
|
45
|
|
WBPA
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Whole Body Periodic Acceleration on Airway Endothelial Function
Baseline characteristics by cohort
| Measure |
Whole Body Periodic Acceleration (WBPA)
n=45 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Qaw post minus Qaw pre albuterol after WBPA or Sham WBPAPopulation: controls n =15, smokers N=15 , asthma N=15
Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.
Outcome measures
| Measure |
WBPA
n=45 Participants
Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
|
Sham WBPA
n=45 Participants
Subjects will be resting on the platform without any WBPA.
|
|---|---|---|
|
Airway Blood Flow Response to Albuterol
Smokers n=15,15
|
2.85 μl/min/ml
Standard Error 2.33
|
-1.43 μl/min/ml
Standard Error 2.8
|
|
Airway Blood Flow Response to Albuterol
Controls N=15, 15
|
17.93 μl/min/ml
Standard Error 2.08
|
4.03 μl/min/ml
Standard Error 0.8
|
|
Airway Blood Flow Response to Albuterol
Asthma N=15,15
|
1.96 μl/min/ml
Standard Error 2.06
|
1.65 μl/min/ml
Standard Error 0.8
|
Adverse Events
Whole Body Periodic Acceleration (WBPA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham WBPA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place