Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received on February 19, 2008. Last Updated on December 16, 2011 History of Changes

Sponsor:	Allergopharma Joachim Ganzer KG
Information provided by (Responsible Party):	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00623701

Purpose

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

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

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:

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Further study details as provided by Allergopharma Joachim Ganzer KG:

Primary Outcome Measures:

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

Estimated Enrollment:	226
Study Start Date:	March 2008
Estimated 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623701

Locations

Sponsors and Collaborators

Allergopharma Joachim Ganzer KG

Investigators

Principal Investigator:

Kristian Reich, Professor

not affiliated

More Information

Additional Information:

Leader in specific allergy research and therapy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00623701 History of Changes
Other Study ID Numbers:	AL0703st
Study First Received:	February 19, 2008
Last Updated:	December 16, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma Joachim Ganzer 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 February 09, 2012