Immunological Tests Clinical Trial
Official title:
A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject. - Healthy subjects (except the condition studied in the ALLERGY group). - A male or female between, and including 18 and 45 years of age at the time of study start. - Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group). - Subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for ALLERGY group). - A positive skin prick test response realised and/or a positive test for specific IgE against birch within the last 5 years (only for ALLERGY group). Exclusion Criteria: - Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol. - Receipt of blood products 120 days prior to study visit. - Receipt of immunoglobulin 120 days prior to study visit. - Use of any investigational or non-registered product within 30 days preceding the study visit. - Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. - Any confirmed or suspected autoimmune or inflammatory disorders. - Administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. Purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit. - Pregnant or lactating female. - Any past or current birch-specific immunotherapy (only for ALLERGY group). - Any allergic disease as established by medical history before study start (only for CONTROL group). - Family history of allergic diseases in the first degree family members (only for CONTROL group). |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Belgium | GSK Investigational Site | Gent | |
| Belgium | GSK Investigational Site | La Louvière |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of antigen-specific Th2 CD4+ T cells | At Day 0 | No | |
| Secondary | Measurement of antigen-specific Th1 CD4+ T cells | At Day 0 | No |