NCT01191359

Brief Summary

Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

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

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

August 27, 2010

Last Update Submit

February 7, 2013

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch

    specific antibody determination

    after 4, 8, 12, 24, 36 weeks of treatment

Secondary Outcomes (1)

  • Comparison of the two administration routes with regard to safety aspects

    36 weeks

Study Arms (2)

sublingual administration

ACTIVE COMPARATOR

oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose)

Biological: oral immunotherapy

vestibular administration

ACTIVE COMPARATOR

oral immunotherapy with drops applied by single dose containers (200 STU per dose)

Biological: oral immunotherapy

Interventions

oral immunotherapyBIOLOGICAL

orally applied specific immunotherapy

Also known as: SLITone birch
sublingual administrationvestibular administration

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of Birch pollen allergy
  • Positive skin prick test to birch
  • Positive specific IgE to birch

You may not qualify if:

  • Uncontrolled or severe asthma (FEV1\<70% of predicted value in spite of adequate pharmacologic treatment)
  • Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
  • Concomitant SLIT with any allergen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Bonn, Dermatology

Bonn, D-53127, Germany

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Thomas Bieber, MD, PhD

    Universitäsklinik Bonn, Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 30, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

DE(1)