Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-12-31

Brief Summary

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The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).

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Detailed Description

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The main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma… ) with the aim of identifying novel inflammatory markers.

Conditions

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GRAZAX

Group Type EXPERIMENTAL

GRAZAX

Intervention Type DRUG

GRAZAX

Interventions

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GRAZAX

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No