Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

Detailed Description
-----------------
Version 1 16/02/2011 The allergen-specific immunotherapy represents an important therapeutic option for the treatment of allergic respiratory diseases. Its clinical efficacy is well demonstrated, although the mechanism of action is still under study. The main purpose of immunotherapy is to induce an allergen-specific tolerance so that the natural exposure to the allergen does not cause clinical symptoms. The clinical efficacy of standard subcutaneous immunotherapy (SCIT) is known. A meta-analysis Cochrane on the clinical efficacy of SCIT in allergic rhinitis 51 double-blind studies with a total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction in the use of drugs in 57%. Other studies also show that SCIT was effective in the long term (at least 3-5 years of suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and the use of asthma medications. Sublingual immunotherapy (SLIT) represents an effective alternative route of administration of vaccine therapy with an allergic profile security than the SCIT.

Official Title
-----------------
Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy in Patients With Ragweed Pollinosis: a Phase III Randomized and Controlled Clinical Study

Conditions
-----------------
Pollen Allergy

Intervention / Treatment
-----------------
* Biological: Slit One
* Biological: Slit One
* Biological: Slit One ragweed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-55 years Known allergy to ragweed pollen No immunotherapy or in progress prior to enrollment Symptoms of rhino / conjunctivitis with or without asthma Exclusion Criteria: Allergic to perennial allergens (moulds, mites and animal when exposed to the animal) Patients with chronic diseases (infectious, autoimmune cancer, heart or kidney) Are pregnant Chronic drug treatment with steroids and / or immunosuppressive Oral disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sublingual immunotherapy<br>15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 | Biological: Slit One<br>* slit one sublingual immunotherapy 200 stu<br>* Other names: Slitone (Alk Abello);|
| Active Comparator: vestibular immunotherapy<br>15 patients treated with vestibular immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 | Biological: Slit One<br>* slit one vestibular immunotherapy 200 stu<br>* Other names: Slitone (Alk Abello);|
| Active Comparator: sublingual doubled immunotherapy<br>15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at doubled dose (400 STU / dose) from June to August 2001 | Biological: Slit One ragweed<br>* slit one 400 stu dose ragweed (sublingual doubled immunotherapy)<br>* Other names: Slitone (Alk Abello);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific (ragweed) in pre-seasonal SLIT vs oral-vestibular regimen and in pre-seasonal regimen of SLIT at 400 STU/dose vs 200 STU |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually |  | 3 months | 
| Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose |  | 3 months | 
| Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually |  | 3 months | 
| Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose |  | 3 months |