NCT01719133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

29 days

First QC Date

October 26, 2012

Last Update Submit

October 31, 2012

Conditions

Allergic Rhinitis

Keywords

allergybirch

Outcome Measures

Primary Outcomes (1)

  • skin prick test reactivity

    15 minutes

Study Arms (1)

All subjects

OTHER

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

Drug: placeboDrug: HistamineDrug: AllerT1Drug: AllerT2Drug: AllerT3Drug: AllerT4Drug: AllerT5Drug: mix of AllerT1-T2-T3Drug: mix of AllerT4-T5

Interventions

placeboDRUG

saline solution

Also known as: saline
All subjects
HistamineDRUG

positive control

Also known as: Histamine solution
All subjects
AllerT1DRUG

synthetic peptide T1

All subjects
AllerT2DRUG

synthetic peptide T2

All subjects
AllerT3DRUG

synthetic peptide T3

All subjects
AllerT4DRUG

synthetic peptide T4

All subjects
AllerT5DRUG

synthetic peptide T5

All subjects
mix of AllerT1-T2-T3DRUG

mix of peptides T1, T2 and T3

Also known as: AllerT
All subjects
mix of AllerT4-T5DRUG

mix T4-T5

Also known as: mix T4-T5
All subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • history of allergy symptoms during previous birch pollen season
  • positive skin prick test to birch pollen extract

You may not qualify if:

  • pregnancy
  • uncontrolled asthma
  • other significant clinical conditions or immune disorders
  • subjects taking antihistamines or drugs with antihistamine activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 23725004DERIVED

MeSH Terms

Conditions

Rhinitis, AllergicHypersensitivity

Interventions

Sodium ChlorideHistamine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Francois Spertini, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2012

First Posted

November 1, 2012

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

June 1, 2008

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

CH(1)