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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00410930 |
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Date of registration:
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12/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
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Scientific title:
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Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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160 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00410930 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Gabrielle PAULI, MD, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Liautey - Strasbourg, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or
mild asthma range 1 and 2 GINA.
- Positive history of birch pollen allergy (clinical history, positive skin prick
test, birch specific IgE, presence of birch pollen)
- Compliant patients
- Written consent.
Exclusion Criteria:
- Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal
danders, mites, alternaria cladosporium
- Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
- Patients treated with beta-blockers or under continuous oral corticosteroids.
- Pregnant women
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergy
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Intervention(s)
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Biological: Subcutaneous immunotherapy - Recombinant birch pollen
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Primary Outcome(s)
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Reduction of symptom and medication scores.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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