Status:
UNKNOWN
A Randomised, Double-blind, Placebo Controlled Study With Oralgen Grass Pollen Rhinoconjunctivitis
Lead Sponsor:
Artu Biologicals
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 anticipa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT00812799
Start Date
December 1 2008
End Date
December 1 2011
Last Update
April 30 2010
Active Locations (60)
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1
AZ St Jan, Campus Sint-Jan
Bruges, Belgium, B-8000
2
Clinique Saint Luc
Brussels, Belgium, B-1200
3
U.Z. St Raphael
Leuven, Belgium, B-3000
4
University Hospital Leuven
Leuven, Belgium, B-3000