Last updated: 11/03/2018 17:48:45
Study in allergic adults to support the development of immunological assays
GSK study ID
115315
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study in adult subjects with allergy to support the development of immunological assays
Trial description: The purpose of this study is to develop and characterize immunological assays on blood samples.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subject responders with antigen specific Lymphocytes T helper 2 (Th2) cluster of differentiation 4+ (CD4+) T cells expressing cytokines
Timeframe: At Day 0
Number of subject responders with antigen specific Th2 CD4+ T cells expressing cytokines - amended definition
Timeframe: At Day 0
Secondary outcomes:
Number of subject responders with antigen-Th2 CD4+ T cells expressing interferon-gamma (IFN-γ)
Timeframe: At Day 0
Number of subject responders with antigen-Th2 CD4+ T cells expressing IFN-γ - amended definition
Timeframe: At Day 0
Interventions:
Enrollment:
80
Primary completion date:
2011-11-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Immunologic Tests
Product
GSK2231392A
Collaborators
Not applicable
Study date(s)
March 2011 to May 2011
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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).
Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-11-05
Actual study completion date
2011-11-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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