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

NCT01500642 | Completed Phase 3

• 1 other identifier: 130/2011/29/AP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

sublingual immunotherapy

ACTIVE COMPARATOR

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

vestibular immunotherapy

ACTIVE COMPARATOR

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

sublingual doubled immunotherapy

ACTIVE COMPARATOR

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

Interventions

Slit One BIOLOGICAL

slit one sublingual immunotherapy 200 stu

Also known as: Slitone (Alk Abello)

sublingual immunotherapy

Slit One ragweed BIOLOGICAL

slit one 400 stu dose ragweed (sublingual doubled immunotherapy)

Also known as: Slitone (Alk Abello)

sublingual doubled immunotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead
• ALK-Abelló A/S: collaborator

Study Sites (1)

Luigi Sacco Hospital

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• enrico iemoli, phd

  luigi sacco hospital milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director allergy and clinical immunology department

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

IT (1)