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

This study is ongoing, but not recruiting participants.
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: April 29, 2013
Last verified: April 2013
History of Changes

August 26, 2011
April 29, 2013
August 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
Reduction of the risk of an asthma exacerbation. [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
Number of asthma exacerbations reported in the IMP treated groups compared to number of asthma exacerbations reported in the placebo group.
Complete list of historical versions of study NCT01433523 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Difference in changes in immunological parameters (IgE, IgG4) [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
  • Time to first severe asthma exacerbation after ICS reduction [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
  • Frequency of asthma exacerbations following ICS reduction [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
  • The average overall symptom score. [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
  • Symptom free days [ Time Frame: Measured during the last 4 months of the trial (months 14-18) ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with treatment emergent AEs [ Time Frame: At end of trial (14-18 months) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma
Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: ALK HDM AIT Placebo
    Oral lyophilisate, Placebo, to be administered sublingually once daily
  • Drug: ALK HDM AIT 6 DU
    Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
  • Drug: ALK HDM AIT 12 DU
    Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
  • Placebo Comparator: Placebo
    Intervention: Drug: ALK HDM AIT Placebo
  • Experimental: ALK HDM AIT 6 DU
    Intervention: Drug: ALK HDM AIT 6 DU
  • Experimental: ALK HDM AIT 12 DU
    Intervention: Drug: ALK HDM AIT 12 DU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
July 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01433523
MT-04
No
ALK-Abelló A/S
ALK-Abelló A/S
  • Ergomed
  • ACM Pivotal Global Central Laboratory
Principal Investigator: Christian Virchow, Prof.Dr.med. Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
ALK-Abelló A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP