Status:
COMPLETED
In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Allergic
Asthmatic
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation by the allergen D. farinae, comparing basophil activation before and after seven days of supplementation. Se...
Detailed Description
Oxidant stress plays an important role in mucosal inflammation such as seen with asthma. Previous studies have also shown that asthmatic individuals tend to have lower endogenous levels of antioxidant...
Eligibility Criteria
Inclusion
- 1\. Specific allergy to House Dust Mite farinae confirmed by positive immediate skin test response.
- 2\. Oxygen saturation of \> 94 % at baseline 3. Blood pressure within the following parameters (Systolic between 140 - 90, Diastolic between 90-60 mm Hg) 4. Moderate or severe persistent asthma according to NHLBI definitions including history of one of the following:
- Episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity
- Asthma symptoms occurring at night or during sleep at least 1 time per week
- measured FEV1 or FVC is \<80% of predicted OR
- Physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled B2-agonist
Exclusion
- 1\. Any chronic medical condition considered by the PI as a contraindication to receiving gamma-T, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
- 2\. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) which have been used for at least one month are allowed. Patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study.
- 3\. Non-steroidal Anti-Inflammatory Drugs (NSAIDS) or aspirin (ASA) use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study.
- 4\. Use of anticoagulants including warfarin, heparin, or clopidogrel. 5. Diagnosis of anemia or abnormal blood counts at screening. Abnormal PT or PTT values at screening (PT that is prolonged more than 1-2 sec and PTT prolonged more than 3-5 sec of normal. The normal values used will be those defined by McLendon lab.) 6. Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified.
- 7\. Children will not be included in this study as the potential risk to a growing child cannot be justified.
- 8\. Adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
- 9\. Known vagal response to venipuncture 10. Use of any tobacco product within the past 6 months 11. Hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00836368
Start Date
December 1 2008
End Date
December 1 2010
Last Update
November 7 2011
Active Locations (1)
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1
Center for Environmental Medicine Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599