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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812799
Recruitment Status : Unknown
Verified April 2010 by Artu Biologicals.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2008
Last Update Posted : April 30, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Oralgen Other: placebo control Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2008
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Grass pollen extract
Subjects will receive 19.000 BU grass pollen extract daily sublingually
Drug: Oralgen
19.000 BU daily
Other Name: Grass pollen extract
Placebo Comparator: Placebo control
Subjects will receive matching placebo control daily sublingually
Other: placebo control
placebo control

Primary Outcome Measures :
  1. Difference between active and placebo-group based on combined RTSS and RMS score [ Time Frame: third season ]

Secondary Outcome Measures :
  1. Difference between active and placebo based on RTSS score [ Time Frame: third season ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812799

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Sponsors and Collaborators
Artu Biologicals
Study Director: Folkert Roossien Artu-Biologicals Europe B.V.

Responsible Party: Dr. F.F. Roossien, Artu Biologicals Europe B.V. Identifier: NCT00812799     History of Changes
Other Study ID Numbers: AB0801
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Artu Biologicals:
efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
grass pollen extract

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases