AsthmaPhase 3MITRANCT01433523
House Dust Mite Treatment of Asthma. The MITRA Trial House Dust Mite Treatment of Asthma
A Phase 3 study testing ALK HDM AIT 6 DU and ALK HDM AIT 12 DU in people with Asthma, run by ALK-Abelló A/S at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- ALK HDM AIT 6 DU and ALK HDM AIT 12 DU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 834 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6
Rostock, 18057
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- ALK HDM AIT Placebo, ALK HDM AIT 6 DU, ALK HDM AIT 12 DU
- Keywords
- HDM, AIT, asthma, asthma exacerbation, House dust mite induced asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK HDM AIT PlaceboDrug
Oral lyophilisate, Placebo, to be administered sublingually once daily
ALK HDM AIT 6 DUDrug
Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
ALK HDM AIT 12 DUDrug
Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: ALK HDM AIT Placebo |
| ALK HDM AIT 6 DU | Experimental | Not described Receives: Drug: ALK HDM AIT 6 DU |
| ALK HDM AIT 12 DU | Experimental | Not described Receives: Drug: ALK HDM AIT 12 DU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first moderate or severe asthma exacerbation after ICS reduction
Measured: Measured during the last 6 months of the trial
Secondary outcomes (6)
Difference in changes in immunological parameters (IgE, IgG4)
Measured: Measured at the end of the trial
Time to first severe asthma exacerbation after ICS reduction
Measured: Measured during the last 6 months of the trial
Frequency of asthma exacerbations following ICS reduction
Measured: Measured during the last 6 months of the trial
The average overall symptom score.
Measured: Measured during the last 6 months of the trial
Symptom free days
Measured: Measured during the last 6 months of the trial
Number and percentage of subjects with treatment emergent AEs
Measured: At end of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed, ACM Pivotal Global Central Laboratory
- Responsible party
- Sponsor
- Investigators
- Christian Virchow, Prof.Dr.med., Principal investigator, Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433523
- Sponsor's protocol ID
- MT-04
- Other IDs
- 2010-018621-19
- Acronym
- MITRA
- Status last verified
- Jan 2017
- First submitted
- 26 Aug 2011
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoof I, Bonnelykke K, Stranzl T, Brand S, Li X, Shamji MH, Meyers DA, Bateman ED, Bleecker E, Andersen PS. Genetic and T2 biomarkers linked to the efficacy of HDM sublingual immunotherapy in asthma. Thorax. 2024 Mar 15;79(4):332-339. doi: 10.1136/thorax-2023-220707.
PubMed 38160049Fortescue 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ALK House Dust Mite Allergy Immunotherapy Tablet in Subjects With House Dust Mite Induced Asthma. The MITRA Trial
- ClinicalTrials.gov ID
- NCT01433523
- Acronym / sponsor ID
- MITRA / MT-04
- Conditions
- Asthma
- Keywords
- HDM, AIT, asthma, asthma exacerbation, House dust mite induced asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed, ACM Pivotal Global Central Laboratory
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: ALK HDM AIT Placebo |
| ALK HDM AIT 6 DU | Experimental | Drug: ALK HDM AIT 6 DU |
| ALK HDM AIT 12 DU | Experimental | Drug: ALK HDM AIT 12 DU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALK HDM AIT PlaceboOral lyophilisate, Placebo, to be administered sublingually once daily | Drug | Placebo |
| ALK HDM AIT 6 DUOral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months. | Drug | ALK HDM AIT 6 DU |
| ALK HDM AIT 12 DUOral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months. | Drug | ALK HDM AIT 12 DU |
Primary outcome
Time to first moderate or severe asthma exacerbation after ICS reduction
Time frame: Measured during the last 6 months of the trial
6 secondary outcomes
Difference in changes in immunological parameters (IgE, IgG4)
Time frame: Measured at the end of the trial
Time to first severe asthma exacerbation after ICS reduction
Time frame: Measured during the last 6 months of the trial
Frequency of asthma exacerbations following ICS reduction
Time frame: Measured during the last 6 months of the trial
The average overall symptom score.
Time frame: Measured during the last 6 months of the trial
Symptom free days
Time frame: Measured during the last 6 months of the trial
Number and percentage of subjects with treatment emergent AEs
Time frame: At end of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 38160049Hoof I, Bonnelykke K, Stranzl T, Brand S, Li X, Shamji MH, Meyers DA, Bateman ED, Bleecker E, Andersen PS. Genetic and T2 biomarkers linked to the efficacy of HDM sublingual immunotherapy in asthma. Thorax. 2024 Mar 15;79(4):332-339. doi: 10.1136/thorax-2023-220707.
- Derived from this study: PubMed 32926419Fortescue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Virchow, Prof.Dr.med. principal investigator
Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALK HDM AIT 6 DU and ALK HDM AIT 12 DU in people with Asthma, run by ALK-Abelló A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01433523, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.