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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
Sponsor:
Information provided by:
Medical University of Lodz

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: prednisone, lactose Drug: prednisone, colecalciferol, lactose Drug: lactose Drug: montelukast sodium Phase 3

Detailed Description:
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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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:
  • Miflonide
  • Pulmicort
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:
  • Miflonide
  • Pulmicort
Placebo Comparator: III Drug: lactose

Allergen immunotherapy (build-up phase)premedication with orally administrated in the day of immunotherapy:

0.3mg lactose

Other Names:
  • Miflonide
  • Pulmicort
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:
  • Miflonide
  • Pulmicort
Placebo Comparator: B Drug: lactose
Allergen immunotherapy (build-up phase)premedication with 0,3mg lactose once daily at bedtime
Other Names:
  • Miflonide
  • Pulmicort


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Poland
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical University of Lodz
Investigators
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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
More Information
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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
Keywords provided by Medical University of Lodz:
allergen immunotherapy premedication
Additional relevant MeSH terms:
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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