House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial

Conditions
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Asthma

Intervention / Treatment
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* Drug: ALK HDM AIT Placebo
* Drug: ALK HDM AIT 6 DU
* Drug: ALK HDM AIT 12 DU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: ALK HDM AIT Placebo<br>* Oral lyophilisate, Placebo, to be administered sublingually once daily<br>|
| Experimental: ALK HDM AIT 6 DU<br> | Drug: ALK HDM AIT 6 DU<br>* Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.<br>|
| Experimental: ALK HDM AIT 12 DU<br> | Drug: ALK HDM AIT 12 DU<br>* Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first moderate or severe asthma exacerbation after ICS reduction |  | Measured during the last 6 months of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in changes in immunological parameters (IgE, IgG4) |  | Measured at the end of the trial | 
| Time to first severe asthma exacerbation after ICS reduction |  | Measured during the last 6 months of the trial | 
| Frequency of asthma exacerbations following ICS reduction |  | Measured during the last 6 months of the trial | 
| The average overall symptom score. |  | Measured during the last 6 months of the trial | 
| Symptom free days |  | Measured during the last 6 months of the trial | 
| Number and percentage of subjects with treatment emergent AEs |  | At end of trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HDM, AIT, asthma, asthma exacerbation, House dust mite induced asthma