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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623701
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

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

Condition or disease Intervention/treatment Phase
Allergy Rhinitis Conjunctivitis Biological: Allerslit forte Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Symptom and Medication Score [ Time Frame: Grass pollen season 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic disease
  • other perennial allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00623701

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

Additional Information:
Responsible Party: Allergopharma GmbH & Co. KG Identifier: NCT00623701     History of Changes
Other Study ID Numbers: AL0703st
2007-000823-16 ( EudraCT Number )
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

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

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