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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artu Biologicals

Criteria

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