Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191359

Enrollment

Registered

2010-08-30

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Brief summary

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

Interventions

BIOLOGICALoral immunotherapy

orally applied specific immunotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch	after 4, 8, 12, 24, 36 weeks of treatment	specific antibody determination

Secondary

Measure	Time frame	Description
Comparison of the two administration routes with regard to safety aspects	36 weeks	adverse events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026