N/A
Completed N=80
Study in Allergic Adults to Support the Development of Immunological Assays
Immunologic Tests
Source: ClinicalTrials.gov NCT01320137 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines — 7; 1; 7; 0 Subjects
Summary
The purpose of this study is to develop and characterize immunological assays on blood samples.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines |
7; 1; 7; 0 | — |
| PRIMARY Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition |
6; 0; 7; 1 | — |
| SECONDARY Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ) |
8; 3 | — |
| SECONDARY Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition |
8; 2 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01320137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.