Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

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: NCT00567346
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : May 5, 2010
Information provided by:
Artu Biologicals

Brief Summary:
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Drug: Oralgen Drug: grass pollen extract Phase 2 Phase 3

Detailed Description:
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
Study Start Date : December 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Active Comparator: grass pollen extract twice weekly
Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given.
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Name: grass pollen extract

Active Comparator: Grass pollen extract, daily
Grass pollen immunotherapy, 9,500 BU, given daily
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Name: grass pollen extract

Active Comparator: Increased dose of grass pollen extract
Increased dose of grass pollen immunotherapy, 19,000 BU, given daily
Drug: Oralgen
Patients will receive drops of grass pollen immunotherapy sublingually
Other Name: grass pollen extract

Placebo Comparator: Placebo control
Patients randomized to placebo will receive placebo daily.
Drug: grass pollen extract
Patients will receive matching placebo sublingually
Other Name: Placebo control

Primary Outcome Measures :
  1. Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests. [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female aged 18-50
  • patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
  • Positive skin prick test and IgE value of at least Class 2+
  • RTSS of greater or equal to 14 during pollen season prior tot the start of the study
  • Patients must be in general good health
  • Patients with normal spirometry
  • Informed consent given and willing to comply with the protocol
  • Female patients are eligible if they use an accepted contraceptive method
  • Negative urine pregnancy test if female

Exclusion Criteria:

  • Pregnancy, breast feeding
  • Asthma requiring treatment other than beta-2 inhaled agonists
  • patients who have taken oral steroids within 12 weeks before screening visit
  • patients who have received desensitisation treatment for grass pollen
  • treatment by immunotherapy with any other allergen within the previous 5 years
  • patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
  • patients at risk of non-compliance
  • participation in any other clinical study within the previous 3 months
  • patients with a past or current disease, which may affect participation in or outcome of this study.
  • patients treated with beta-blockers or under continuous corticotherapy
  • allergic sensitivity to epithelial allergens the patients is exposed to
  • positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
  • intention to subject the patient to surgery of the nasal cavity during current study
  • Usual contraindications of immunotherapy
  • a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season

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): NCT00567346

  Show 40 Study Locations
Sponsors and Collaborators
Artu Biologicals
Study Director: Folkert R Roossien Artu-Biologicals Europe B.V., the Netherlands

Responsible Party: Dr. F.F. Roosien, Artu Biologicals Identifier: NCT00567346     History of Changes
Other Study ID Numbers: AB0602
2006-001548-30 ( EudraCT Number )
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 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