Pharmacological Modulations of Allergen-Specific Immunotherapy
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ClinicalTrials.gov Identifier: NCT00504946 |
Recruitment Status :
Completed
First Posted : July 20, 2007
Last Update Posted : April 11, 2008
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Drug: prednisone, lactose Drug: prednisone, colecalciferol, lactose Drug: lactose Drug: montelukast sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
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Active Comparator: I |
Drug: prednisone, lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 20mg prednisone+ 0.3mg lactose Other Names:
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Active Comparator: II |
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 Other Names:
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Placebo Comparator: III |
Drug: lactose
Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy: 0.3mg lactose Other Names:
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Active Comparator: A |
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
Other Names:
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Placebo Comparator: B |
Drug: lactose
Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
Other Names:
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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) ]
- 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) ]
- 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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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 β2-agonist, leukotriene modifiers, β-blockers (eye drops included) or oral corticosteroids within 6 month before the pre-study visit.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504946
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: | Medical Universtity of Lodz, Department of Pediatrics and Allergy |
ClinicalTrials.gov Identifier: | NCT00504946 |
Other Study ID Numbers: |
RNN-168-05-KE |
First Posted: | July 20, 2007 Key Record Dates |
Last Update Posted: | April 11, 2008 |
Last Verified: | April 2008 |
allergen immunotherapy premedication |
Cholecalciferol Vitamin D Vitamins Prednisone Budesonide Montelukast Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |
Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Calcium-Regulating Hormones and Agents Micronutrients Bone Density Conservation Agents |