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
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 |
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
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Luigi Sacco Hospital | Milano |
Lead Sponsor | Collaborator |
---|---|
Ospedale L. Sacco – Polo Universitario | ALK-Abelló A/S |
Italy,
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 |
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