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

ALK-Abelló

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: ALK HDM AIT Placebo; Drug: ALK HDM AIT 12 DU; Drug: ALK HDM AIT 6 DU

Study type: Interventional

Funder types: Industry

Identifiers

NCT01433523

2010-018621-19 (EudraCT Number)

MT-04

Details and patient eligibility

About

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.

Enrollment: 834 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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834 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: ALK HDM AIT Placebo

ALK HDM AIT 6 DU

Experimental group

Treatment:

Drug: ALK HDM AIT 6 DU

ALK HDM AIT 12 DU

Experimental group

Treatment:

Drug: ALK HDM AIT 12 DU