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Completed

NCT Number: NCT01433523

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

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6

Rostock, 18057, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALK HDM AIT Placebo

Drug

Oral lyophilisate, Placebo, to be administered sublingually once daily

ALK HDM AIT 6 DU

Drug

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

ALK HDM AIT 12 DU

Drug

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

Primary outcomes

  1. Time to first moderate or severe asthma exacerbation after ICS reduction

    Time frame: Measured during the last 6 months of the trial

Secondary outcomes

  1. Difference in changes in immunological parameters (IgE, IgG4)

    Time frame: Measured at the end of the trial

  2. Time to first severe asthma exacerbation after ICS reduction

    Time frame: Measured during the last 6 months of the trial

  3. Frequency of asthma exacerbations following ICS reduction

    Time frame: Measured during the last 6 months of the trial

  4. The average overall symptom score.

    Time frame: Measured during the last 6 months of the trial

  5. Symptom free days

    Time frame: Measured during the last 6 months of the trial

  6. Number and percentage of subjects with treatment emergent AEs

    Time frame: At end of trial

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Collaborators

  • ACM Pivotal Global Central Laboratory
  • Ergomed

Registry information

Official study title

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

Acronym: MITRA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 14, 2011
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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