- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433523
House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma (MITRA)
January 27, 2017 updated by: ALK-Abelló A/S
Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial
The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
834
Phase
- Phase 3
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
-
-
-
Rostock, Germany, 18057
- Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
-
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- A clinical relevant history consistent with house dust mite induced asthma of at least 1 year prior to trial entry.
- Use of an appropriate amount of inhaled corticosteroid for the control of asthma symptoms.
- Documented reversible airway obstruction.
- Suitable level of asthma control.
- FEV1 ≥ 70% of predicted value.
- Positive Skin Prick Test response to Der pte and/or Der far.
- Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).
Key Exclusion Criteria:
- A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites).
- A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period from October to March.
- Any clinically relevant chronic disease.
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Oral lyophilisate, Placebo, to be administered sublingually once daily
|
EXPERIMENTAL: ALK HDM AIT 6 DU
|
Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
|
EXPERIMENTAL: ALK HDM AIT 12 DU
|
Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first moderate or severe asthma exacerbation after ICS reduction
Time Frame: Measured during the last 6 months of the trial
|
Measured during the last 6 months of the trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in changes in immunological parameters (IgE, IgG4)
Time Frame: Measured at the end of the trial
|
Measured at the end of the trial
|
Time to first severe asthma exacerbation after ICS reduction
Time Frame: Measured during the last 6 months of the trial
|
Measured during the last 6 months of the trial
|
Frequency of asthma exacerbations following ICS reduction
Time Frame: Measured during the last 6 months of the trial
|
Measured during the last 6 months of the trial
|
The average overall symptom score.
Time Frame: Measured during the last 6 months of the trial
|
Measured during the last 6 months of the trial
|
Symptom free days
Time Frame: Measured during the last 6 months of the trial
|
Measured during the last 6 months of the trial
|
Number and percentage of subjects with treatment emergent AEs
Time Frame: At end of trial
|
At end of trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Virchow, Prof.Dr.med., Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2011
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
August 26, 2011
First Submitted That Met QC Criteria
September 13, 2011
First Posted (ESTIMATE)
September 14, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 30, 2017
Last Update Submitted That Met QC Criteria
January 27, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-04
- 2010-018621-19 (EUDRACT_NUMBER)
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.
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