A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis

Phase 3

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Oralgen; Other: placebo control

• Registration Number: NCT00812799
• Lead Sponsor: Artu Biologicals

Brief Summary

This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

Detailed Description

Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-04-30
• Primary Completion: 2011-08
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• male or female
• grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons
• positive skin prick test RRTSS greater or equal to 12 during the 2008 season
• signed informed consent

Exclusion Criteria

• positive skin prick test for other environmental allergens and suffering from serious allergic symptoms
• clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season
• clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed
• lacking of good health
• abnormal spirometry
• lower respiratory tract infection
• asthma requiring treatment other than beta-2 agonists
• oral steroids within 12 weeks before screening
• regular contraindications for use of immunotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grass pollen extract	Oralgen	Subjects will receive 19.000 BU grass pollen extract daily sublingually
Placebo control	placebo control	Subjects will receive matching placebo control daily sublingually

Primary Outcome Measures

Name	Time	Method
Difference between active and placebo-group based on combined RTSS and RMS score	third season

Secondary Outcome Measures

Name	Time	Method
Difference between active and placebo based on RTSS score	third season

Trial Locations

Locations (60)

AZ St Jan, Campus Sint-Jan; 🇧🇪 Brugge, Belgium

Clinique Saint Luc; 🇧🇪 Bruxelles, Belgium

U.Z. St Raphael; 🇧🇪 Leuven, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium

CHR de la Citadelle; 🇧🇪 Liege, Belgium

Clinique UCL de Mont-Godinne; 🇧🇪 Yvoir, Belgium

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Gael Taburet; 🇫🇷 Brest, France

Francois Durand Perdriel; 🇫🇷 Nantes, France

Francois Wessel; 🇫🇷 Nantes, France

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