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

Overview

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.

Full Title of Study: “A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2011

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.

Interventions

  • Drug: Oralgen
    • 19.000 BU daily
  • Other: placebo control
    • placebo control

Arms, Groups and Cohorts

  • Active Comparator: Grass pollen extract
    • Subjects will receive 19.000 BU grass pollen extract daily sublingually
  • Placebo Comparator: Placebo control
    • Subjects will receive matching placebo control daily sublingually

Clinical Trial Outcome Measures

Primary Measures

  • Difference between active and placebo-group based on combined RTSS and RMS score
    • Time Frame: third season

Secondary Measures

  • Difference between active and placebo based on RTSS score
    • Time Frame: third season

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Artu Biologicals
  • Provider of Information About this Clinical Study
    • Dr. F.F. Roossien, Artu Biologicals Europe B.V.
  • Overall Official(s)
    • Folkert Roossien, Study Director, Artu-Biologicals Europe B.V.

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