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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Artu Biologicals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Artu Biologicals
ClinicalTrials.gov Identifier:
NCT00812799
First received: December 19, 2008
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Allergic Rhinoconjunctivitis
Drug: Oralgen
Other: placebo control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Artu Biologicals:

Primary Outcome Measures:
  • Difference between active and placebo-group based on combined RTSS and RMS score [ Time Frame: third season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between active and placebo based on RTSS score [ Time Frame: third season ] [ Designated as safety issue: No ]

Enrollment: 374
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812799

  Show 60 Study Locations
Sponsors and Collaborators
Artu Biologicals
Investigators
Study Director: Folkert Roossien Artu-Biologicals Europe B.V.
  More Information

No publications provided

Responsible Party: Dr. F.F. Roossien, Artu Biologicals Europe B.V.
ClinicalTrials.gov Identifier: NCT00812799     History of Changes
Other Study ID Numbers: AB0801
Study First Received: December 19, 2008
Last Updated: April 29, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
France: Institutional Ethical Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Artu Biologicals:
randomised
double-blind
placebo-controlled
efficacy and safety
Oralgen® Grass Pollen
allergic rhinoconjunctivitis
allergy
rhinoconjunctivitis
immunotherapy
grass pollen extract

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

ClinicalTrials.gov processed this record on October 23, 2014