Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Phase 2CompletedNCT01191359

ALK-Abelló A/S66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Allergy

Interventions

oral immunotherapyBIOLOGICAL

orally applied specific immunotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinik Bonn, Dermatology

Bonn, Germany

Outcomes

Primary Outcomes

Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch

specific antibody determination

Time frame: after 4, 8, 12, 24, 36 weeks of treatment

Secondary Outcomes

Comparison of the two administration routes with regard to safety aspects

adverse events

Time frame: 36 weeks

Data from ClinicalTrials.gov

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