Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Phase 3CompletedNCT00671268

Allergopharma GmbH & Co. KG256 enrolled

Overview

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Rhinoconjunctivitis

Interventions

AL0704rPBIOLOGICAL

strict subcutaneous

PlaceboBIOLOGICAL

strict subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Allergic rhinoconjunctivitis attributable to grass pollen * Positive SPT * Positive EAST * Positive provocation test Exclusion Criteria: * serious disease * other perennial allergies

Locations (1)

Allergopharma GmbH & Co. KG

Reinbek, Germany

Outcomes

Primary Outcomes

Change of Symptom and Medication score

Time frame: during the baseline and the following two pollen seasons

Data from ClinicalTrials.gov

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