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

• Sponsor: Allergopharma GmbH & Co. KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00623701
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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; Biological: Allerslit forte	Phase 3

Study Design

• Study Type: Interventional
• 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: Mar 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Symptom and Medication Score [Grass pollen season 2009]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Kristian Reich, MD	Hamburg		Germany	20354

Sponsors and Collaborators

• Allergopharma GmbH & Co. KG

Investigators

• Principal Investigator: Kristian Reich, Professor, not affiliated

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Leader in specific allergy research and therapy
• Click here for information about this trial in the European Clinical Trials Register

Publications

None provided.

• Responsible Party: Allergopharma GmbH & Co. KG
• ClinicalTrials.gov Identifier: NCT00623701
• Other Study ID Numbers: AL0703st; 2007-000823-16
• First Posted: Feb 26, 2008
• Last Update Posted: Nov 8, 2013
• Last Verified: Nov 1, 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

Study Results

No Results Posted as of Nov 8, 2013