Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation (ALLEGRA6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00623701
First received: February 19, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Allergy
Rhinitis
Conjunctivitis
Biological: Allerslit forte
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Symptom and Medication Score [ Time Frame: Grass pollen season 2009 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: March 2008
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
sublingual placebo preparation
Biological: Allerslit forte
sublingual placebo preparation, daily
Experimental: 2
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose
Biological: Allerslit forte
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allergic rhinoconjunctivitis attributable to grass pollen
  • Positive SPT
  • Positive EAST
  • Positive provocation Test

Exclusion Criteria:

  • Serious chronic disease
  • other perennial allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623701

Locations
Germany
Prof. Kristian Reich, MD
Hamburg, Germany, 20354
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Kristian Reich, Professor not affiliated
  More Information

Additional Information:
No publications provided

Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00623701     History of Changes
Other Study ID Numbers: AL0703st, 2007-000823-16
Study First Received: February 19, 2008
Last Updated: November 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:
sublingual grass pollen preparation
IgE-mediated Allergic Disease attributed to grass pollen

Additional relevant MeSH terms:
Conjunctivitis
Rhinitis
Conjunctival Diseases
Eye Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014