Efficacy and Safety from a high-dosed sublingual grass pollen...
Date First Received: February 19, 2008
Last Updated: July 14, 2008
Verified by: Allergopharma Joachim Ganzer KG, July 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2008
Overall Status: Recruiting
Estimated Enrollment: 226
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: October 2011
Intervention(s) in this Clinical Trial
- Biological: Allerslit forte
- sublingual placebo preparation, daily
- Biological: Allerslit forte
- Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- sublingual placebo preparation
- Experimental: 2
- Sublingual preparation, 40 micro grams Phl p 5 maintenance dose
Outcome Measures for this Clinical Trial
Primary Measures
- Symptom and Medication Score
- Time Frame: Grass pollen season 2009
Safety Issue?: No
- Time Frame: Grass pollen season 2009
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation Test
Exclusion Criteria:
- Serious chronic disease
- other perennial allergies
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Allergopharma Joachim Ganzer KG
Overall Clinical Trial Officials and Contacts
Kristian Reich, Professor Principal Investigator not affiliated
Overall Contact: Viola Sprung, Dipl. Dok. +0049-40-72765-0 Viola.Sprung@allergopharma.de
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00623701
Study ID Number: AL0703st
ClinicalTrials.gov Identifier: NCT00623701
Health Authority: Germany: Paul-Ehrlich-Institut
Clinical Trials Authorship and Review
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