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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-02-28

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

ALK HDM AIT Placebo

Intervention Type DRUG

Oral lyophilisate, Placebo, to be administered sublingually once daily

ALK HDM AIT 6 DU

Group Type EXPERIMENTAL

ALK HDM AIT 6 DU

Intervention Type DRUG

Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.

ALK HDM AIT 12 DU

Group Type EXPERIMENTAL

ALK HDM AIT 12 DU

Intervention Type DRUG

Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

Interventions

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ALK HDM AIT Placebo

Oral lyophilisate, Placebo, to be administered sublingually once daily

Intervention Type DRUG

ALK HDM AIT 6 DU

Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.

Intervention Type DRUG

ALK HDM AIT 12 DU

Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

Intervention Type DRUG

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No