Back to resultsEfficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
Primary Purpose
Allergic Asthma
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Pangramin Plus D. pteronyssinus 100%
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Asthma focused on measuring Specific immunotherapy, Mite, Asthma
Eligibility 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
Sites / Locations
- Hospital Virgen del Camino, Allergology Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Pangramin Plus Dermatophagoides pteronyssinus 100%
Pangramin Plus placebo
Outcomes
Primary Outcome Measures
Reduction in inhaled corticosteroids
Secondary Outcome Measures
Reduction in symptoms and rescue medication Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00492076
Brief Title
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Specific immunotherapy, Mite, Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Pangramin Plus Dermatophagoides pteronyssinus 100%
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Pangramin Plus placebo
Intervention Type
Biological
Intervention Name(s)
Pangramin Plus D. pteronyssinus 100%
Intervention Description
Active. Pangramin Plus D. pteronyssinus 100%
Placebo. Pangramin Plus placebo
Primary Outcome Measure Information:
Title
Reduction in inhaled corticosteroids
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Reduction in symptoms and rescue medication Tolerability
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana I Tabar, MD PhD
Organizational Affiliation
Hospital Virgen del Camino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen del Camino, Allergology Service
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31002
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
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