Pharmacological Modulations of Allergen-Specific Immunotherapy - Full Text View

Sponsored by:	Medical Universtity of Lodz
Information provided by:	Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00504946

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 III

MedlinePlus related topics: Asthma

Drug Information available for: Prednisone Vitamin D Ergocalciferol Cholecalciferol Lactose Montelukast sodium Montelukast Budesonide

U.S. FDA Resources

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

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

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

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

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
Health Authority:	Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:

allergen immunotherapy premedication

Study placed in the following topic categories:

Montelukast
Prednisone
Cholecalciferol
Vitamin D

Budesonide
Ergocalciferols
Asthma
Leukotriene Antagonists

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Bone Density Conservation Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Vitamins
Therapeutic Uses
Peripheral Nervous System Agents
Micronutrients
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009