Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

NCT ID: NCT01191359

Last Updated: 2013-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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

Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sublingual administration

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

Group Type ACTIVE_COMPARATOR

oral immunotherapy

Intervention Type BIOLOGICAL

orally applied specific immunotherapy

vestibular administration

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

Group Type ACTIVE_COMPARATOR

oral immunotherapy

Intervention Type BIOLOGICAL

orally applied specific immunotherapy

Interventions

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oral immunotherapy

orally applied specific immunotherapy

Intervention Type BIOLOGICAL

Other Intervention Names

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SLITone birch

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Bieber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitäsklinik Bonn, Dermatology

Locations

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Universitätsklinik Bonn, Dermatology

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SP-B-02

Identifier Type: -

Identifier Source: org_study_id

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