Effect of HSA or Saline Diluent on Immunotherapy Extract Stability as Determined by Graded ID Skin Tests
| Status: | Completed |
|---|---|
| Conditions: | Allergy |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/2/2016 |
| Start Date: | March 2013 |
| End Date: | December 2013 |
| Contact: | Bryan Martin, DO |
| Email: | bryan.martin@osumc.edu |
| Phone: | 614-2934975 |
This is a double-blind study with respect to the diluents used, with patients known to be
allergic to the specific allergen tested. Three study sites will be involved, each testing
one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the
allergen in question will be tested with serial three-fold dilutions to determine the ID 50
and relative extract potency using the method described by Turkeltaub.
allergic to the specific allergen tested. Three study sites will be involved, each testing
one allergen (Cat, Mite, Timothy grass pollen). Subjects who are known to be allergic to the
allergen in question will be tested with serial three-fold dilutions to determine the ID 50
and relative extract potency using the method described by Turkeltaub.
The specific objective of this study is to determine the stability of immunotherapy extract
dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency
over time more rapidly than less dilute preparations. The investigators hope to determine
whether there is a detectable difference in skin test reaction of dilutions of three common
antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength
when extract potency is tested in vitro. Therefore, the investigators expect to find a
detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline
[300mcg/ml]).
dilutions. Higher dilutions (lower potency) have been shown in vitro to decrease in potency
over time more rapidly than less dilute preparations. The investigators hope to determine
whether there is a detectable difference in skin test reaction of dilutions of three common
antigens (Cat, Timothy Grass, Dust Mite). The diluents used strongly affect the strength
when extract potency is tested in vitro. Therefore, the investigators expect to find a
detectable difference in skin test potency based on the diluents used (Saline vs. HSA Saline
[300mcg/ml]).
Inclusion Criteria:
- 1. Subjects must demonstrate their willingness to participate in the study and comply
with its procedures by signing a written informed consent.
2. Subjects of either gender, ages 18-60 years, with a history of allergic rhinitis
related to exposure to the allergen of interest.
3. Previous positive routine skin test to the allergen to be tested: minimum 5mm
wheal diameter with 10,000BAU/mL cat or minimum 5mm wheal diameter with 10,000AU/mL
Dermatophagoides farinae or minimum 8mm wheal diameter with timothy 100,000BAU/mL.
4. AND (in addition to #3) sum of erythema after SPT of at least 50mm or erythema in
largest diameter of at least 30mm.
5. Subject's skin coloring should permit evaluation of erythema. 6. Ability to stop
medication that might interfere with the results of the skin prick test.
Exclusion Criteria:
- 1. Spirometry with FEV1 below 80% of predicted normal value and/or poorly controlled
asthma 2. Known pregnancy 3. Patients with a history of anaphylaxis or severe allergic
reactions. 4. Patients with absolute necessity of antihistamines to control their
allergies 5. Patients with active and extensive atopic dermatitis. 6. Patients that take
psychotropic medication. 7. General skin hyperreactivity (Negative control greater than 3
mm wheal diameter) or with known tendency for dermatographic urticaria.
8. Patients currently under allergen immunotherapy treatment or with a history of
immunotherapy treatment within the last 5 years to the extract to be tested in this study
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