Trial | NCT00492076  Report issue

Title

Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
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.
Study Started
Oct 31
2006
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Oct 16
2008
Estimate

Biological Pangramin Plus D. pteronyssinus 100%

Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo

2 Placebo Comparator

Pangramin Plus placebo

1 Active Comparator

Pangramin Plus Dermatophagoides pteronyssinus 100%

Criteria 

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
No Results Posted