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

This study has been completed.
Sponsor:
Collaborators:
Ergomed
ACM Pivotal Global Central Laboratory
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01433523
First received: August 26, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: ALK HDM AIT Placebo
Drug: ALK HDM AIT 6 DU
Drug: ALK HDM AIT 12 DU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Time to first moderate or severe asthma exacerbation after ICS reduction [ Time Frame: Measured during the last 6 months of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in changes in immunological parameters (IgE, IgG4) [ Time Frame: Measured at the end of the trial ] [ Designated as safety issue: No ]
  • Time to first severe asthma exacerbation after ICS reduction [ Time Frame: Measured during the last 6 months of the trial ] [ Designated as safety issue: No ]
  • Frequency of asthma exacerbations following ICS reduction [ Time Frame: Measured during the last 6 months of the trial ] [ Designated as safety issue: No ]
  • The average overall symptom score. [ Time Frame: Measured during the last 6 months of the trial ] [ Designated as safety issue: No ]
  • Symptom free days [ Time Frame: Measured during the last 6 months of the trial ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with treatment emergent AEs [ Time Frame: At end of trial ] [ Designated as safety issue: Yes ]

Enrollment: 834
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: ALK HDM AIT Placebo
Oral lyophilisate, Placebo, to be administered sublingually once daily
Experimental: ALK HDM AIT 6 DU Drug: ALK HDM AIT 6 DU
Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
Experimental: ALK HDM AIT 12 DU Drug: ALK HDM AIT 12 DU
Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433523

Locations
Germany
Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
Rostock, Germany, 18057
Sponsors and Collaborators
ALK-Abelló A/S
Ergomed
ACM Pivotal Global Central Laboratory
Investigators
Principal Investigator: Christian Virchow, Prof.Dr.med. Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01433523     History of Changes
Other Study ID Numbers: MT-04
Study First Received: August 26, 2011
Last Updated: March 21, 2014
Health Authority: Austria: Federal Office for Safety in Health Care (BASG)
Croatia: Ministry of Health and Social Welfare
Denmark: Danish Medicines Agency (DKMA)
France: French Health Products Safety Agency (AFSSAPS)
Germany: Paul-Ehrlich Institute
Latvia: State Agency of Medicines (SAM)
Lithuania: State Medicines Control Agency (SMCA)
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocides
Serbia: Medicines and Medical Devices Agency of Serbia
Slovakia: State Institute for Drug Control (SIDC)
Spain: Spanish Drug and Health Products Agency (AEMPS)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALK-Abelló A/S:
HDM
AIT
asthma
asthma exacerbation
House dust mite induced asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014