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

Primary Purpose

Allergy, Rhinitis, Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Allerslit forte
Allerslit forte
Sponsored by
Allergopharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic disease
  • other perennial allergies

Sites / Locations

  • Prof. Kristian Reich, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

sublingual placebo preparation

Sublingual preparation, 40 micro grams Phl p 5 maintenance dose

Outcomes

Primary Outcome Measures

Symptom and Medication Score

Secondary Outcome Measures

Full Information

First Posted
February 19, 2008
Last Updated
November 7, 2013
Sponsor
Allergopharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00623701
Brief Title
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
Acronym
ALLEGRA6
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Rhinitis, Conjunctivitis
Keywords
sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
sublingual placebo preparation
Arm Title
2
Arm Type
Experimental
Arm Description
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose
Intervention Type
Biological
Intervention Name(s)
Allerslit forte
Intervention Description
sublingual placebo preparation, daily
Intervention Type
Biological
Intervention Name(s)
Allerslit forte
Intervention Description
Sublingual preparation, 40 micro grams Phl p 5 maintenance dose,daily
Primary Outcome Measure Information:
Title
Symptom and Medication Score
Time Frame
Grass pollen season 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to grass pollen Positive SPT Positive EAST Positive provocation Test Exclusion Criteria: Serious chronic disease other perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Reich, Professor
Organizational Affiliation
not affiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Kristian Reich, MD
City
Hamburg
ZIP/Postal Code
20354
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-000823-16/DE
Description
Click here for information about this trial in the European Clinical Trials Register

Learn more about this trial

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

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