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: 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

Primary Measures

• Symptom and Medication Score
  • Time Frame: Grass pollen season 2009
    Safety Issue?: No

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

Lead Sponsor: Allergopharma Joachim Ganzer KG

Overall Clinical Trial Officials and Contacts

Kristian Reich, Professor Principal Investigator not affiliated  

Information obtained from ClinicalTrials.gov on July 02, 2009

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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