Pharmacological Modulations of Allergen-Specific Immunotherapy

• ClinicalTrials.gov Identifier: NCT00504946
• Recruitment Status: Completed
• First Posted: July 20, 2007
• Last Update Posted: April 11, 2008
• Sponsor: Medical University of Lodz
• Information provided by: Medical University of Lodz

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

Poland

Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland

Lodz, Poland, 93-513

Sponsors and Collaborators

Medical University 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: 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
• Last Update Posted: April 11, 2008
• Last Verified: April 2008

Keywords provided by Medical University of Lodz:

allergen immunotherapy premedication

Additional relevant MeSH terms:

Vitamins; Cholecalciferol; 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