House Dust Mite AllergyPhase 3MT-06NCT01454544
A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
A Phase 3 study testing AIT Tablet in people with House Dust Mite Allergy, run by ALK-Abelló A/S at 1 site in France.
Trial summary
The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits. Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- House Dust Mite Allergy
- What is being tested?
- AIT Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 992 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Apr 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of house dust mite allergy
- Use of symptomatice medication for treatment of house dust mite allergy
- Positive skin prick test to mites
- Positive specific IgE
Who cannot join
- History of uncontrolled asthma
- Overlapping symptomatice allergies
- Previous treatment with immunotherapy
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Respiratory Diseases, Lapeyronie Hospital
Montpellier, Montpellier, 34295
About this study
The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.
Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.
Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.
- Conditions
- House Dust Mite Allergy
- Being tested
- AIT Tablet
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIT TabletBiological
1 tablet per day in 12 months
| Study group | Role | What they receive |
|---|---|---|
| ALK house dust mite tablet 6 DU | Experimental | Not described Receives: Biological: AIT Tablet |
| ALK house dust mite tablet 12 DU | Experimental | Not described Receives: Biological: AIT Tablet |
| Placebo | Placebo comparator | Not described Receives: Biological: AIT Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of allergy symptoms and use of symptomatic medication
Comparing the daily recording of symptoms and use of symptomatic medication during the last period of the trial between the actively treated patients and the placebo treated.
Measured: 1 year with treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for House Dust Mite AllergyStudies 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
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454544
- Sponsor's protocol ID
- MT-06
- Other IDs
- 2011-002277-38
- Acronym
- MT-06
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2011
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
PubMed 29656145
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
- A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet
- ClinicalTrials.gov ID
- NCT01454544
- Acronym / sponsor ID
- MT-06 / MT-06
- Conditions
- House Dust Mite Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Oct 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 primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.
Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.
Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.
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 |
|---|---|---|
| ALK house dust mite tablet 6 DU | Experimental | Biological: AIT Tablet |
| ALK house dust mite tablet 12 DU | Experimental | Biological: AIT Tablet |
| Placebo | Placebo comparator | Biological: AIT Tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A history of house dust mite allergy
- Use of symptomatice medication for treatment of house dust mite allergy
- Positive skin prick test to mites
- Positive specific IgE
Key exclusion criteria (3 listed)
- History of uncontrolled asthma
- Overlapping symptomatice allergies
- Previous treatment with immunotherapy
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 |
|---|---|---|
| AIT Tablet1 tablet per day in 12 months | Biological | ALK house dust mite tablet 12 DU, ALK house dust mite tablet 6 DU, Placebo |
Primary outcome
Evaluation of allergy symptoms and use of symptomatic medication
Time frame: 1 year with treatment
Comparing the daily recording of symptoms and use of symptomatic medication during the last period of the trial between the actively treated patients and the placebo treated.
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 29656145Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.
- SQ house dust mite (HDM) SLIT-tablet provides clinical improvement in HDM-induced allergic rhinitisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AIT Tablet in people with House Dust Mite Allergy, run by ALK-Abelló A/S at 1 site in France.
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 4 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 France. 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?
Evaluation of allergy symptoms and use of symptomatic medication (time frame: 1 year with treatment). 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 NCT01454544, which also lists 1 linked publication.
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.