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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500642
First Posted: December 28, 2011
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ALK-Abelló A/S
Information provided by (Responsible Party):
Iemoli Enrico, Ospedale L. Sacco - Polo Universitario
  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
Intervention Model: Parallel Assignment
Masking: None (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 Iemoli Enrico, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500642


Locations
Italy
Luigi Sacco Hospital
Milano, Italy, 20157
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
ALK-Abelló A/S
Investigators
Principal Investigator: enrico iemoli, phd luigi sacco hospital milano
  More Information

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
First Submitted: December 22, 2011
First Posted: December 28, 2011
Last Update Posted: January 5, 2012
Last Verified: January 2012

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