Status:
COMPLETED
Exhaled Levels of Nitric Oxide
Lead Sponsor:
VA Office of Research and Development
Conditions:
Tetraplegia
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Previously it was observed that individuals with tetraplegia have reduced baseline airway caliber and exhibit non-specific airway hyperresponsiveness (AHR). In persons with tetraplegia we have suggest...
Detailed Description
The study requires a maximum of five study visits in the following order: 1. nebulized normal saline, 2. nebulized 1mg/kg of L-NAME (see below), 3. intravenous normal saline, 4. intravenous 1 mg/kg L-...
Eligibility Criteria
Inclusion
- Written informed consent.
- Age between 18 and 65 years.
- Able-bodied individuals, persons with mild asthma or individuals with tetraplegia for at least one year of duration.
- Able to perform acceptable pulmonary function tests and follow procedures.
Exclusion
- coronary artery disease;
- active cigarette smokers or previous smokers who stopped \<5 years ago;
- MI or stroke within 3 months;
- moderate to severe reduction in lung function defined as FEV1 \< 70 % predicted (except in individuals with tetraplegia);
- hypertension;
- medications known to affect the cardiovascular system;
- pregnancy
- current use of cholinesterase medication; and
- lack of mental capacity to give informed consent Group specific exclusion criteria for
- Asthmatic subjects:
- Moderate to severe disease as per spirometric indices;
- testing within 48 hours of last administration of long acting inhaled bronchodilator;
- testing within 7 days of last administration of glucocorticoids;
- testing within \> 24 hours since last administration of leukotriene modifiers; and
- testing within 8 hours of last administration of a short acting bronchodilator medication
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00753948
Start Date
December 1 2006
End Date
August 1 2010
Last Update
February 28 2020
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468