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

Pollen Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500642
• Other study ID #: 130/2011/29/AP
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2011
• Last updated: January 4, 2012
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pollen Allergy
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Slit One
slit one sublingual immunotherapy 200 stu
• Slit One
slit one vestibular immunotherapy 200 stu
• Slit One ragweed
slit one 400 stu dose ragweed (sublingual doubled immunotherapy)

Locations

Country	Name	City	State
Italy	Luigi Sacco Hospital	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario	ALK-Abelló A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes