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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 20, 2014