Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

ALK-Abelló

Status and phase: Completed; Phase 2

Conditions: Allergy

Treatments: Biological: oral immunotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191359

SP-B-02

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

sublingual administration

Active Comparator group

Description:

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

Treatment:

Biological: oral immunotherapy

vestibular administration

Active Comparator group

Description:

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

Treatment:

Biological: oral immunotherapy