Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
Efficacy and Safety from a high-dosed sublingual grass pollen...
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”
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- 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 Investigator Information
Lead Investigator: Allergopharma Joachim Ganzer KG Industry
Overall Clinical Trial Officials and Contacts
Kristian Reich, Professor Principal Investigator not affiliated
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00623701
