Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Drug: Oralgen
* Drug: grass pollen extract


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 twice weekly<br>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<br>* Patients will receive drops of grass pollen immunotherapy sublingually<br>* Other names: grass pollen extract;|
| Active Comparator: Grass pollen extract, daily<br>Grass pollen immunotherapy, 9,500 BU, given daily | Drug: Oralgen<br>* Patients will receive drops of grass pollen immunotherapy sublingually<br>* Other names: grass pollen extract;|
| Active Comparator: Increased dose of grass pollen extract<br>Increased dose of grass pollen immunotherapy, 19,000 BU, given daily | Drug: Oralgen<br>* Patients will receive drops of grass pollen immunotherapy sublingually<br>* Other names: grass pollen extract;|
| Placebo Comparator: Placebo control<br>Patients randomized to placebo will receive placebo daily. | Drug: grass pollen extract<br>* Patients will receive matching placebo sublingually<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | one year | 

 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