Allergy Clinical Trial
— ALLEGRA6Official title:
A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
Verified date | November 2013 |
Source | Allergopharma GmbH & Co. KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
Status | Completed |
Enrollment | 126 |
Est. completion date | October 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Allergic rhinoconjunctivitis attributable to grass pollen - Positive SPT - Positive EAST - Positive provocation Test Exclusion Criteria: - Serious chronic disease - other perennial allergies |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Prof. Kristian Reich, MD | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Allergopharma GmbH & Co. KG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom and Medication Score | Grass pollen season 2009 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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