Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

Phase 3CompletedNCT00554983

Allergopharma GmbH & Co. KG255 enrolled

Overview

Efficacy and Safety from a recombinant folding variant of Bet v 1

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

255

Conditions

Allergy

Interventions

recombinant birch pollen allergenBIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

placeboBIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Allergic rhinoconjunctivitis attributable to birch pollen * Positive SPT * Positive EAST * Positive specific provocation test Exclusion Criteria: * Serious chronic diseases * Other perennial allergies

Locations (1)

Allergopharma GmbH & Co. KG

Reinbek, Germany

Outcomes

Primary Outcomes

Symptom-Medication-Score

Time frame: during pollen season

Data from ClinicalTrials.gov

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