Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
Sponsored by ALK-Abelló A/S
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 11 years ago
What is this trial about?
What are the participation requirements?
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.