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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719133
First Posted: November 1, 2012
Last Update Posted: November 1, 2012
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.
Information provided by (Responsible Party):
Anergis
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anergis:

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

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01719133


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
Anergis
Investigators
Principal Investigator: Francois Spertini, MD Centre Hospitalier Universitaire Vaudois
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anergis
ClinicalTrials.gov Identifier: NCT01719133     History of Changes
Other Study ID Numbers: AN002
First Submitted: October 26, 2012
First Posted: November 1, 2012
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Anergis:
allergy
birch

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs