CClinicalTrials.gg
Sign In
CompletedNCT01433523MITRAUpdated Jan 30, 2017

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

A Phase 3 interventional study of ALK HDM AIT Placebo and ALK HDM AIT 6 DU in Asthma, sponsored by ALK-Abelló A/S. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
834
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • HDM
  • AIT
  • asthma
  • asthma exacerbation
  • House dust mite induced asthma
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 834 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
834 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: ALK HDM AIT Placebo

  • Experimental
    ALK HDM AIT 6 DU

    Drug: ALK HDM AIT 6 DU

  • Experimental
    ALK HDM AIT 12 DU

    Drug: ALK HDM AIT 12 DU

Interventions

  • DrugALK HDM AIT Placebo

    Oral lyophilisate, Placebo, to be administered sublingually once daily

  • DrugALK HDM AIT 6 DU

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

  • DrugALK HDM AIT 12 DU

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

06

What researchers measure

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

07

Study locations

1 site
  • Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
    Rostock, 18057, Germany
08

References and documents

Publications

  • Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3. PubMed 32926419 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01433523
Lead sponsor
ALK-Abelló A/S
Collaborators
Ergomed, ACM Pivotal Global Central Laboratory
Responsible party
Sponsor
First posted
Sep 14, 2011
Start date
Aug 2011
Primary completion
Apr 2013
Completion
Feb 2014
Last update
Jan 30, 2017

Study contacts

Christian Virchow, Prof.Dr.med.
principal investigator · Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

ALK-Abelló A/S

Start the discussion