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

This study has been completed.
Sponsor:
Collaborator:
ALK-Abelló A/S
Information provided by (Responsible Party):
Iemoli Enrico, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier:
NCT01500642
First received: December 22, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Pollen Allergy
Biological: Slit One
Biological: Slit One ragweed
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ospedale L. Sacco – Polo Universitario:

Primary Outcome Measures:
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sublingual immunotherapy
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
slit one sublingual immunotherapy 200 stu
Other Name: Slitone (Alk Abello)
Active Comparator: vestibular immunotherapy
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
slit one vestibular immunotherapy 200 stu
Other Name: Slitone (Alk Abello)
Active Comparator: sublingual doubled immunotherapy
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
slit one 400 stu dose ragweed (sublingual doubled immunotherapy)
Other Name: Slitone (Alk Abello)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500642

Locations
Italy
Luigi Sacco Hospital
Milano, Italy, 20157
Sponsors and Collaborators
Ospedale L. Sacco – Polo Universitario
ALK-Abelló A/S
Investigators
Principal Investigator: enrico iemoli, phd luigi sacco hospital milano
  More Information

No publications provided

Responsible Party: Iemoli Enrico, director allergy and clinical immunology department, Ospedale L. Sacco - Polo Universitario
ClinicalTrials.gov Identifier: NCT01500642     History of Changes
Other Study ID Numbers: 130/2011/29/AP
Study First Received: December 22, 2011
Last Updated: January 4, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014