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

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

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

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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