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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623701
First Posted: February 26, 2008
Last Update Posted: November 8, 2013
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.
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
  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
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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00623701     History of Changes
Other Study ID Numbers: AL0703st
2007-000823-16 ( EudraCT Number )
First Submitted: February 19, 2008
First Posted: February 26, 2008
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:
Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases