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NCT00623701 Clinical Trial

Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

Allergy Clinical Trial

— ALLEGRA6  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00623701
Other study ID # AL0703st
Secondary ID 2007-000823-16
Status Completed
Phase Phase 3
First received February 19, 2008
Last updated November 7, 2013
Start date March 2008
Est. completion date October 2012

Study information
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

Clinical Trial Summary

Efficacy and Safety from a high-dosed sublingual grass pollen preparation

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Allerslit forte
sublingual placebo preparation, daily
• Allerslit forte
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily

Locations
Country Name City State
Germany Prof. Kristian Reich, MD Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom and Medication Score Grass pollen season 2009 No
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