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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01127035 |
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Date of registration:
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19/05/2010 |
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Primary sponsor: |
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Public title:
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Sublingual Immunotherapy In Alternaria-Induced Rhinitis
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Scientific title:
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STUDIO IN DOPPIO CIECO DISODIOCROMOGLICATO + PLACEBO vs DISODIOCROMOGLICATO + IMMUNOTERAPIA SPECIFICA SUBLINGUALE PER ALTERNARIA IN PAZIENTI CON RINITE ALLERGICA DOVUTA A SENSIBILIZZAZIONE AD ALTERNARIA |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01127035 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Allergic rhinitis
- Symptoms May-October
- Specific IgE to alternaria (skin test/radioallergosorbent [RAST] test)
- Age >14
Exclusion Criteria:
- Sensitization to mites, parietaria, mugwort
- Pregnancy-lactation
- Malignancies
- Chronic systemic steroids
- Previous immunotherapy to alternaria
Age minimum:
14 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic Rhinitis (w/w Asthma) Due to Alternaria Alternata
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Intervention(s)
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Biological: placebo
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Biological: sublingual immunotherapy
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Primary Outcome(s)
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change in symptom score active versus placebo
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Secondary Outcome(s)
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change in rescue medication intake
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Secondary ID(s)
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SLITALT2004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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