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

ASST Fatebenefratelli Sacco

Status and phase: Completed; Phase 3

Conditions: Pollen Allergy

Treatments: Biological: Slit One; Biological: Slit One ragweed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01500642

130/2011/29/AP

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

sublingual immunotherapy

Active Comparator group

Description:

15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001

Treatment:

Biological: Slit One

Biological: Slit One

vestibular immunotherapy

Active Comparator group

Description:

15 patients treated with vestibular immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001

Treatment:

Biological: Slit One

Biological: Slit One

sublingual doubled immunotherapy

Active Comparator group

Description:

15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at doubled dose (400 STU / dose) from June to August 2001

Treatment:

Biological: Slit One ragweed