Allergic Asthma Clinical Trial
Official title:
A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma
Verified date | October 2008 |
Source | ALK-Abelló A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Virgen del Camino, Allergology Service | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
ALK-Abelló A/S |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in inhaled corticosteroids | 4 months | No | |
Secondary | Reduction in symptoms and rescue medication Tolerability | 4 months | Yes |
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