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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: ALK HDM AIT 6 DU; Drug: ALK HDM AIT 12 DU; Drug: ALK HDM AIT Placebo

• Registration Number: NCT01433523
• Lead Sponsor: ALK-Abelló A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Primary Completion: 2013-04
• Study Completion: 2014-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALK HDM AIT 6 DU	ALK HDM AIT 6 DU	-
ALK HDM AIT 12 DU	ALK HDM AIT 12 DU	-
Placebo	ALK HDM AIT Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to first moderate or severe asthma exacerbation after ICS reduction	Measured during the last 6 months of the trial

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6; 🇩🇪 Rostock, Germany