Pharmacological Modulations of Allergen-Specific Immunotherapy

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00504946
First received: July 19, 2007
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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
Asthma
Drug: prednisone, lactose
Drug: prednisone, colecalciferol, lactose
Drug: lactose
Drug: montelukast sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

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
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504946

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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

No publications provided

Responsible Party: Medical Universtity of Lodz, Department of Pediatrics and Allergy
ClinicalTrials.gov Identifier: NCT00504946     History of Changes
Other Study ID Numbers: RNN-168-05-KE
Study First Received: July 19, 2007
Last Updated: April 8, 2008
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
allergen immunotherapy premedication

Additional relevant MeSH terms:
Montelukast
Prednisone
Cholecalciferol
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014