NCT00818181

Brief Summary

This trial is performed to assess safety of a sublingual birch pollen extract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

January 6, 2009

Last Update Submit

March 8, 2013

Conditions

Rhinoconjunctivitis

Keywords

Type I - Allergy, rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • number of patients with at least one adverse event

    Between Visit 03 and Visit 05 (June 2008 - January 2009)

    8 months

Secondary Outcomes (1)

  • Systemic reactions

    Entire treatment period

Other Outcomes (1)

  • Immunologic parameters

    during the course of the study

Study Arms (1)

Solution of birch pollen allergen extract

EXPERIMENTAL

In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.

Drug: Biological: AL0206st

Interventions

Biological: AL0206stDRUG
Solution of birch pollen allergen extract

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Allergic rhinoconjunctivitis attributable to birch pollen
  • Positive SPT
  • Positive EAST

You may not qualify if:

  • Serious chronic diseases
  • Other perennial allergies
  • Partly controlled asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Nicolas Hunzelmann

Cologne, 50931, Germany

Location

Related Links

Study Officials

  • Nicolas Hunzelmann, Prof. Dr.

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 7, 2009

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

August 1, 2010

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

DE(1)