Desensitization and Cross-Desensitization During Oral Grass or Ragweed Pollen Immunotherapy

• Status: Terminated
• Trial end date: 2018-01-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if sublingual allergen immunotherapy tablets work by inducing a state of desensitization in mast cells and basophils.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virginia Commonwealth University

Criteria

Inclusion Criteria:

• Verified allergic sensitivity to either Timothy Grass or Short Ragweed pollen (primary allergen)

• Verified allergic sensitivity to at least one allergen in addition to the primary allergen

Exclusion Criteria:

• Negative skin testing to Timothy Grass or Short Ragweed pollen and at least one other environmental allergen

• Dermatographism

• Severe dermatologic condition that may interfere with skin testing

• Pregnancy

• H1 receptor antihistamine taken within 7 days of testing

• Systemic steroids

• Omalizumab taken at any time in the past

• Receiving or received allergen immunotherapy

• Desensitized to any drug within 6 months

• Current uncontrolled or severe asthma

• Eosinophilic esophagitis

• Significant pulmonary, cardiovascular, renal, hepatobiliary, or neurological diseases, or another disease process felt to put a subject at increased risk for adverse events

• Hypersensitivity to any of the inactive ingredients in the allergen extract tablets

• History of mental illness or drug or alcohol abuse that could interfere with the ability to comply with study requirements

• Inability or unwillingness to give written informed consent