Text Size

Study in Allergic Adults to Support the Development of Immunological Assays

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01320137
First received: March 21, 2011
Last updated: September 1, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to develop and characterize immunological assays on blood samples.


Condition Intervention Phase
Immunological Tests
 Procedure: Blood withdrawal
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Measurement of antigen-specific Th2 CD4+ T cells [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of antigen-specific Th1 CD4+ T cells [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
Birch-allergic subjects
 Procedure: Blood withdrawal
Blood sampling
Group B
Healthy subjects
 Procedure: Blood withdrawal
Blood sampling

Detailed Description:

This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320137

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
La Louvière, Belgium, 7100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01320137     History of Changes
Other Study ID Numbers: 115315
Study First Received: March 21, 2011
Last Updated: September 1, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products

Keywords provided by GlaxoSmithKline:
Immunological assay
Birch allergy

ClinicalTrials.gov processed this record on May 22, 2013