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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
placebo
Histamine
AllerT1
AllerT2
AllerT3
AllerT4
AllerT5
mix of AllerT1-T2-T3
mix of AllerT4-T5
Sponsored by
Anergis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Allergic Rhinitis focused on measuring allergy, birch

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of allergy symptoms during previous birch pollen season
  • positive skin prick test to birch pollen extract

Exclusion Criteria:

  • pregnancy
  • uncontrolled asthma
  • other significant clinical conditions or immune disorders
  • subjects taking antihistamines or drugs with antihistamine activity

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All subjects

Arm Description

placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5

Outcomes

Primary Outcome Measures

skin prick test reactivity

Secondary Outcome Measures

Full Information

First Posted
October 26, 2012
Last Updated
October 31, 2012
Sponsor
Anergis
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1. Study Identification

Unique Protocol Identification Number
NCT01719133
Brief Title
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
Official Title
Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anergis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.
Detailed Description
The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter > 4 mm with erythema)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergy, birch

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Other
Arm Description
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
saline
Intervention Description
saline solution
Intervention Type
Drug
Intervention Name(s)
Histamine
Other Intervention Name(s)
Histamine solution
Intervention Description
positive control
Intervention Type
Drug
Intervention Name(s)
AllerT1
Intervention Description
synthetic peptide T1
Intervention Type
Drug
Intervention Name(s)
AllerT2
Intervention Description
synthetic peptide T2
Intervention Type
Drug
Intervention Name(s)
AllerT3
Intervention Description
synthetic peptide T3
Intervention Type
Drug
Intervention Name(s)
AllerT4
Intervention Description
synthetic peptide T4
Intervention Type
Drug
Intervention Name(s)
AllerT5
Intervention Description
synthetic peptide T5
Intervention Type
Drug
Intervention Name(s)
mix of AllerT1-T2-T3
Other Intervention Name(s)
AllerT
Intervention Description
mix of peptides T1, T2 and T3
Intervention Type
Drug
Intervention Name(s)
mix of AllerT4-T5
Other Intervention Name(s)
mix T4-T5
Intervention Description
mix T4-T5
Primary Outcome Measure Information:
Title
skin prick test reactivity
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of allergy symptoms during previous birch pollen season positive skin prick test to birch pollen extract Exclusion Criteria: pregnancy uncontrolled asthma other significant clinical conditions or immune disorders subjects taking antihistamines or drugs with antihistamine activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Spertini, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23725004
Citation
Pellaton C, Perrin Y, Boudousquie C, Barbier N, Wassenberg J, Corradin G, Thierry AC, Audran R, Reymond C, Spertini F. Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides. Clin Transl Allergy. 2013 Jun 1;3(1):17. doi: 10.1186/2045-7022-3-17.
Results Reference
derived

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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

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