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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: |
NCT00698594 |
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Date of registration:
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13/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis
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Scientific title:
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Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00698594 |
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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 (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Poland
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Contacts
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Name:
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Iwona Stelmach, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed
at least 2 years before inclusion into the study
Exclusion Criteria:
- Active upper respiratory tract infection within 3 weeks before the study and acute
sinus disease requiring antibiotic treatment within 1 month before the study
- Allergic rhinitis hospitalisation during the 3 months before the first visit.
- Additional criteria were other clinically significant pulmonary, hematologic,
hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or
psychiatric diseases or malignancy that either put the patient at risk when
participating in the study or could influence the results of the study or the
patient's ability to participate in the study as judged by the investigator.
- Excluded medications were systemic corticosteroids.
- Patients who were receiving immunotherapy were also excluded.
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic Rhinitis
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Intervention(s)
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Biological: sublingual allergen extract
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Biological: placebo
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Primary Outcome(s)
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Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
[Time Frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.]
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Secondary Outcome(s)
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Change of percent of regulatory lymphocytes in the peripheral blood.
[Time Frame: at baseline and at the end of the second season (22 months interval)]
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non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.
[Time Frame: at the end of the first and second season of the study (12 months interval)]
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Secondary ID(s)
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RNN/98/08/KE
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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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