Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

Phase 3CompletedNCT00807547

ALK-Abelló A/S149 enrolled

Overview

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

149

Conditions

Allergy

Interventions

Allergy vaccination (Alutard SQ)BIOLOGICAL

Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * history of grass pollen induced allergic rhinoconjunctivitis * positive skin prick test Exclusion Criteria: * uncontrolled severe bronchial asthma * previous treatment with immunotherapy within the previous 5 years * contraindication for specific immunotherapy

Locations (1)

Center for Rhinology and Allergology

Wiesbaden, Germany

Outcomes

Primary Outcomes

Changes from baseline in Immuno globuline E (IgE)-blocking factor

Time frame: 9 weeks

Secondary Outcomes

Tolerability

Time frame: 9 weeks

Data from ClinicalTrials.gov

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