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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719133
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: placebo Drug: Histamine Drug: AllerT1 Drug: AllerT2 Drug: AllerT3 Drug: AllerT4 Drug: AllerT5 Drug: mix of AllerT1-T2-T3 Drug: mix of AllerT4-T5 Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
Study Start Date : February 2008
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
All subjects
placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5
Drug: placebo
saline solution
Other Name: saline

Drug: Histamine
positive control
Other Name: Histamine solution

Drug: AllerT1
synthetic peptide T1

Drug: AllerT2
synthetic peptide T2

Drug: AllerT3
synthetic peptide T3

Drug: AllerT4
synthetic peptide T4

Drug: AllerT5
synthetic peptide T5

Drug: mix of AllerT1-T2-T3
mix of peptides T1, T2 and T3
Other Name: AllerT

Drug: mix of AllerT4-T5
mix T4-T5
Other Name: mix T4-T5

Primary Outcome Measures :
  1. skin prick test reactivity [ Time Frame: 15 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719133

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Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
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Principal Investigator: Francois Spertini, MD Centre Hospitalier Universitaire Vaudois

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anergis Identifier: NCT01719133     History of Changes
Other Study ID Numbers: AN002
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by Anergis:
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs