Allergic Rhinitis Due to Dust MitePhase 3NCT01199133
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis in Adolescents and Children
A Phase 3 study testing 300 IR house dust mites allergen extract tablet in people with Allergic Rhinitis Due to Dust Mite, run by Stallergenes Greer.
Trial summary
The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Allergic Rhinitis Due to Dust Mite
- What is being tested?
- 300 IR house dust mites allergen extract tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 471 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female outpatients, aged 5-17 years inclusive
- History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
- Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)
Who cannot join
- Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded
- patients sensitised to cat or dog allergens and regularly exposed to these allergens
- patients sensitised to aspergillus, cladosporium, alternaria
- patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region
About this study
Official title: A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.
Read the detailed description
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.
An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.
- Conditions
- Allergic Rhinitis Due to Dust Mite
- Being tested
- 300 IR house dust mites allergen extract tablet, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 IR house dust mites allergen extract tabletDrug
Also called House dust mites (Der p and Der f) allergen extract tablet
One sublingual tablet daily for one year.
Placebo tabletDrug
Also called Sublingual placebo tablet
One sublingual tablet daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| 300 IR | Active comparator | 300 IR house dust mites allergen extract tablet Receives: Drug: 300 IR house dust mites allergen extract tablet |
| Placebo | Placebo comparator | Placebo tablet Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Adjusted Symptom Score (AASS) During the Treatment Period
The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome.
It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake
Measured: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionSep 2011
Why it stopped: Study population was insufficiently symptomatic to enable evaluation of the efficacy of the treatment. No safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to Dust MiteStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Wahn, MD, Study chair, Charite- Campus Virchow klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199133
- Sponsor's protocol ID
- VO64.08
- Other IDs
- 2009-011999-30, 2009
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2010
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.
PubMed 39035788
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised,Double-blind,Placebo-controlled,Multi National,Phase III Trial to Assess the Efficacy and Safety of 300 IR Sublingual Immunotherapy Administered as Allergen-based Tablets Once Daily to Adolescents and Children Above the Age of 5 Years, Suffering From House Dust Mite Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01199133
- Acronym / sponsor ID
- VO64.08
- Conditions
- Allergic Rhinitis Due to Dust Mite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study population was insufficiently symptomatic to enable evaluation of the efficacy of the treatment. No safety concern.
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 11 Feb 2025
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 study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.
Detailed description
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.
An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300 IR | Active comparator | Drug: 300 IR house dust mites allergen extract tablet300 IR house dust mites allergen extract tablet |
| Placebo | Placebo comparator | Drug: Placebo tabletPlacebo tablet |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female outpatients, aged 5-17 years inclusive
- History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
- Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)
Key exclusion criteria (4 listed)
- Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded
- patients sensitised to cat or dog allergens and regularly exposed to these allergens
- patients sensitised to aspergillus, cladosporium, alternaria
- patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region
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 |
|---|---|---|
| 300 IR house dust mites allergen extract tabletAlso: House dust mites (Der p and Der f) allergen extract tabletOne sublingual tablet daily for one year. | Drug | 300 IR |
| Placebo tabletAlso: Sublingual placebo tabletOne sublingual tablet daily for one year. | Drug | Placebo |
Primary outcome
Average Adjusted Symptom Score (AASS) During the Treatment Period
Time frame: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period
The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39035788Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.
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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.
Ulrich Wahn, MD study chair
Charite- Campus Virchow klinikum
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 300 IR house dust mites allergen extract tablet in people with Allergic Rhinitis Due to Dust Mite, run by Stallergenes Greer.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Adjusted Symptom Score (AASS) During the Treatment Period (time frame: Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period). 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 NCT01199133, 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 11 Feb 2025.