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Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anergis
ClinicalTrials.gov Identifier:
NCT01719133
First received: October 26, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Anergis:

Primary Outcome Measures:
  • skin prick test reactivity [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

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
Other Name: AllerT1
Drug: AllerT2
synthetic peptide T2
Other Name: AllerT2
Drug: AllerT3
synthetic peptide T3
Other Name: AllerT3
Drug: AllerT4
synthetic peptide T4
Other Name: AllerT4
Drug: AllerT5
synthetic peptide T5
Other Name: AllerT5
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anergis
ClinicalTrials.gov Identifier: NCT01719133     History of Changes
Other Study ID Numbers: AN002
Study First Received: October 26, 2012
Last Updated: October 31, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Anergis:
allergy
birch

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Histamine
Histamine phosphate
 Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013