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Sponsored by: |
Medical Universtity of Lodz |
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Information provided by: | Medical Universtity of Lodz |
ClinicalTrials.gov Identifier: | NCT00504946 |
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
Condition | Intervention | Phase |
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Asthma |
Drug: prednisone, lactose Drug: prednisone, colecalciferol, lactose Drug: lactose Drug: montelukast sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Enrollment: | 85 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator |
Drug: prednisone, lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose |
II: Active Comparator |
Drug: prednisone, colecalciferol, lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone + 1000j colecalciferol + 0.3mg lactose |
III: Placebo Comparator |
Drug: lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose
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A: Active Comparator |
Drug: montelukast sodium
Allergen immunotherapy (build-up phase)premedication with montelukast sodium. Children 6-14 years received 5 mg of montelukast and children > 14 years old received 10mg oral tablet once daily at bedtime
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B: Placebo Comparator |
Drug: lactose
Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
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There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland | |
Lodz, Poland, 93-513 |
Principal Investigator: | Paweł Majak, MD, PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
Study Chair: | Iwona Stelmach, MD, PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
Responsible Party: | Department of Pediatrics and Allergy ( Medical Universtity of Lodz ) |
Study ID Numbers: | RNN-168-05-KE |
Study First Received: | July 19, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00504946 History of Changes |
Health Authority: | Poland: Ministry of Health |
allergen immunotherapy premedication |
Anti-Inflammatory Agents Cholecalciferol Prednisone Antineoplastic Agents, Hormonal Hormone Antagonists Budesonide Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Asthma Trace Elements Bone Density Conservation Agents |
Glucocorticoids Hormones Leukotriene Antagonists Montelukast Vitamin D Vitamin D3 Vitamins Calciferol Peripheral Nervous System Agents Micronutrients Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Cholecalciferol Prednisone Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Growth Substances Physiological Effects of Drugs Budesonide Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Bone Density Conservation Agents Glucocorticoids Hormones Pharmacologic Actions Leukotriene Antagonists Montelukast Autonomic Agents Therapeutic Uses Vitamins Peripheral Nervous System Agents Micronutrients Bronchodilator Agents |