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Completed

NCT Number: NCT01500642

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luigi Sacco Hospital

Milan, 20157, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slit One

Biological

slit one sublingual immunotherapy 200 stu

Other names: Slitone (Alk Abello)

Slit One ragweed

Biological

slit one 400 stu dose ragweed (sublingual doubled immunotherapy)

Other names: Slitone (Alk Abello)

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

    Time frame: 3 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Collaborators

  • ALK-Abelló A/S

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 28, 2011
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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