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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

NCT ID: NCT01719133

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-06-30

Brief Summary

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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

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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)

Conditions

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Allergic Rhinitis

Keywords

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allergy birch

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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All subjects

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

Group Type OTHER

placebo

Intervention Type DRUG

saline solution

Histamine

Intervention Type DRUG

positive control

AllerT1

Intervention Type DRUG

synthetic peptide T1

AllerT2

Intervention Type DRUG

synthetic peptide T2

AllerT3

Intervention Type DRUG

synthetic peptide T3

AllerT4

Intervention Type DRUG

synthetic peptide T4

AllerT5

Intervention Type DRUG

synthetic peptide T5

mix of AllerT1-T2-T3

Intervention Type DRUG

mix of peptides T1, T2 and T3

mix of AllerT4-T5

Intervention Type DRUG

mix T4-T5

Interventions

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placebo

saline solution

Intervention Type DRUG

Histamine

positive control

Intervention Type DRUG

AllerT1

synthetic peptide T1

Intervention Type DRUG

AllerT2

synthetic peptide T2

Intervention Type DRUG

AllerT3

synthetic peptide T3

Intervention Type DRUG

AllerT4

synthetic peptide T4

Intervention Type DRUG

AllerT5

synthetic peptide T5

Intervention Type DRUG

mix of AllerT1-T2-T3

mix of peptides T1, T2 and T3

Intervention Type DRUG

mix of AllerT4-T5

mix T4-T5

Intervention Type DRUG

Other Intervention Names

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saline Histamine solution AllerT mix T4-T5

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anergis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois Spertini, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 23725004 (View on PubMed)

Other Identifiers

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AN002

Identifier Type: -

Identifier Source: org_study_id