Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

Allergic Rhinitis Clinical Trial

Official title:

Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719133
• Other study ID #: AN002
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2012
• Last updated: October 31, 2012
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: October 2012
• Source: Anergis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• placebo
saline solution
• Histamine
positive control
• AllerT1
synthetic peptide T1
• AllerT2
synthetic peptide T2
• AllerT3
synthetic peptide T3
• AllerT4
synthetic peptide T4
• AllerT5
synthetic peptide T5
• mix of AllerT1-T2-T3
mix of peptides T1, T2 and T3
• mix of AllerT4-T5
mix T4-T5

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Anergis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin prick test reactivity		15 minutes	No