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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01320137 |
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Date of registration:
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21/03/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study in Allergic Adults to Support the Development of Immunological Assays
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Scientific title:
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A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays |
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Date of first enrolment:
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March 31, 2011 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01320137 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Immunologic Tests
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Intervention(s)
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Procedure: Blood withdrawal
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Primary Outcome(s)
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Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
[Time Frame: At Day 0]
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Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
[Time Frame: At Day 0]
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Secondary Outcome(s)
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Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-? - Amended Definition
[Time Frame: At Day 0]
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Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-?)
[Time Frame: At Day 0]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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