Status:
COMPLETED
House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Ergomed
ACM Pivotal Global Central Laboratory
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT01433523
Start Date
August 1 2011
End Date
February 1 2014
Last Update
January 30 2017
Active Locations (1)
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1
Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
Rostock, Germany, 18057