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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: |
NCT00504946 |
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Date of registration:
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19/07/2007 |
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Primary sponsor: |
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Public title:
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Pharmacological Modulations of Allergen-Specific Immunotherapy
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Scientific title:
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The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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85 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00504946 |
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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, Caregiver, Investigator), Primary Purpose: Treatment
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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, MD, PhD |
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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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Name:
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Pawel Majak, MD, PhD |
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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:
- allergic asthma with regular symptoms requiring long-term treatment with inhaled
corticosteroids
- disease duration of at least 2 years
- sensitisation only to house dust mites
- resting FEV1 of more or equal 70%
Exclusion Criteria:
- sensitization to allergens other than house dust mites
- discontinuation of SIT from any reasons
- need of a daily dose below 200 or above 800 mcg of budesonide or equivalent
- other chronic disease including vitamin D3 deficiency and/or resistance which could
influence the results of the study or the patient's ability to participate in the
study as judged by the investigator
- medications that resulted in patient exclusion included: inhaled long acting
ß2-agonist, leukotriene modifiers, ß-blockers (eye drops included) or oral
corticosteroids within 6 month before the pre-study visit.
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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Asthma
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Intervention(s)
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Drug: lactose
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Drug: montelukast sodium
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Drug: prednisone, colecalciferol, lactose
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Drug: prednisone, lactose
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Primary Outcome(s)
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Regulatory T cell (CD4+CD25+Foxp3 positive) induction measured in peripheral blood mononuclear cells
[Time Frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)]
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Secondary Outcome(s)
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Cytokine (IL-10, TGF-beta1, IL-4, IL-5, IL-13) determination in supernatants from peripheral blood mononuclear cells culture.
[Time Frame: First visit, second visit (after 3 months) and third visit (after 12 months of immunotherapy)]
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diary card evaluation with asthma free days estimation, lung function measurement and analysis of reduction of the inhaled corticosteroids dose
[Time Frame: Visit first and third visit (after 12 months of immunotherapy)]
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Secondary ID(s)
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RNN-168-05-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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