Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

Official Title
-----------------
Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

Conditions
-----------------
Grass Pollen Allergy, Hay Fever

Intervention / Treatment
-----------------
* Biological: gpASIT+TM
* Biological: gpASIT+TM
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 50 years Subject has given written informed consent The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status Male or non pregnant, non-lactating female Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period)) Allergy > 2 years Exclusion Criteria: Subjects with current immunotherapy or subjects who underwent a previous immunotherapy within the last 2 years Subjects with perennial asthma Subjects with a VC < 80% and FEV1 < 70% Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) Documented evidence of chronic sinusitis (as determined by investigator) Subjects with a history of hepatic or renal disease Subjects symptomatic to perennial inhalant allergens Subject with malignant disease, autoimmune disease Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD, ...) Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc…) Subjects requiring beta-blockers medication Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants) Subject with febrile illness (> 37.5°C, oral) A known positive serology for HIV-1/2, HBV or HCV The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry Receipt of blood or a blood derivative in the past 6 months preceding trial entry Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial Use of long-acting antihistamines Any condition which could be incompatible with protocol understanding and compliance Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol Participation in another clinical trial and/or treatment with an experimental drug within the last 2 years A history of hypersensitivity to the excipients Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…) Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gpASIT400<br>gpASIT+TM 400 µg | Biological: gpASIT+TM<br>* entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days<br>|
| Experimental: gpASIT800<br>gpASIT+TM 800 µg | Biological: gpASIT+TM<br>* entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Placebo entero-coated capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of gpASIT+TM on the clinical efficacy of the subjects | The following parameter will be assessed: rhinoconjunctivitis total symptom score | grass pollen season 2011 (April to July) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical tolerability and safety of the treatment | The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate) | 8 months | 
| Impact of gpASIT+TM on the immunological status of the subjects | The following parameter will be assessed: allergen-specific immunoglobulin concentrations | screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011) | 
| Impact of gpASIT+TM on the clinical status of the subjects | The average daily symptom and rescue medication scores will be assessed. | grass pollen season 2011 (April-July) | 
| Impact of gpASIT+TM on the quality of life of the subjects | The quality of life will be assessed by the use of validated questionnaires. | grass pollen season 2011 (April-July) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinoconjunctivitis, Allergy, Grass pollen, Hypersensitivity, Immune system disorder