Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
Phase 4
Completed
- Conditions
- Allergic Asthma
- Interventions
- Biological: Pangramin Plus D. pteronyssinus 100%
- Registration Number
- NCT00492076
- Lead Sponsor
- ALK-Abelló A/S
- Brief Summary
The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.
- Detailed Description
The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Mild/moderate persistent asthma
- Positive skin prick test or specific IgE to mites
- Age: 14-55 years old
Exclusion Criteria
- Immunotherapy contraindications
- Allergy to other inhalant allergens
- Previous immunotherapy (5 years)with mites
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pangramin Plus D. pteronyssinus 100% Pangramin Plus Dermatophagoides pteronyssinus 100% 2 Pangramin Plus D. pteronyssinus 100% Pangramin Plus placebo
- Primary Outcome Measures
Name Time Method Reduction in inhaled corticosteroids 4 months
- Secondary Outcome Measures
Name Time Method Reduction in symptoms and rescue medication Tolerability 4 months
Trial Locations
- Locations (1)
Hospital Virgen del Camino, Allergology Service
🇪🇸Pamplona, Navarra, Spain