NCT01500642

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: ASST Fatebenefratelli Sacco · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pollen Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Slit One	slit one sublingual immunotherapy 200 stu
BIOLOGICAL	Slit One	slit one vestibular immunotherapy 200 stu
BIOLOGICAL	Slit One ragweed	slit one 400 stu dose ragweed (sublingual doubled immunotherapy)

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-12-28
• Last updated: 2012-01-05

Locations

1 site across 1 country: Italy