Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX® (GT-20)

This is an interventional other trial for Allergic Rhinoconjunctivitis Read More

Inclusion Criteria:

• Written informed consent obtained before entering the trial.
• Male and female 18-65 years of age.
• A clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry.
• Documented positive specific IgE against grass pollen (IgE ≥ Class 2) into the 5 previous years.
• Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Phleum pratense.
• Negative pregnancy test for childbearing potential females.
• Willing and able to comply with the trial protocol regimen.

Exclusion Criteria:

• Previous treatment by immunotherapy with grass allergen extracts.
• A clinical history of symptomatic perennial allergic rhinitis or asthma.
• Patients with contraindications for immunotherapy as established by the IT subcommittee of the EAACI or in the Summary of Products Characteristics of GRAZAX®.
• Positive pregnancy test (in fertile females).
• Being immediate family of the investigator or trial staff.
• A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.
• Unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period.
• Use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.