Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
October 15, 2008 updated by: ALK-Abelló A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Navarra
-
Pamplona, Navarra, Spain, 31002
- Hospital Virgen del Camino, Allergology Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 55 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Pangramin Plus Dermatophagoides pteronyssinus 100%
|
|
|
PLACEBO_COMPARATOR: 2
Pangramin Plus placebo
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in inhaled corticosteroids
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in symptoms and rescue medication Tolerability
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana I Tabar, MD PhD, Hospital Virgen del Camino
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (ACTUAL)
May 1, 2008
Study Completion (ACTUAL)
May 1, 2008
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 26, 2007
First Posted (ESTIMATE)
June 27, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E04/05/PP-M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.