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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Drug: Oralgen
* Other: placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grass pollen extract<br>Subjects will receive 19.000 BU grass pollen extract daily sublingually | Drug: Oralgen<br>* 19.000 BU daily<br>* Other names: Grass pollen extract;|
| Placebo Comparator: Placebo control<br>Subjects will receive matching placebo control daily sublingually | Other: placebo control<br>* placebo control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between active and placebo-group based on combined RTSS and RMS score |  | third season | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between active and placebo based on RTSS score |  | third season | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, allergy, rhinoconjunctivitis, immunotherapy, grass pollen extract