Pharmacological Modulations of Allergen-Specific Immunotherapy

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lodz; Medical Universtity of Lodz
• Treatments: Budesonide; Cholecalciferol; Montelukast; Prednisone

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.