Allergic Rhinitis Due to House Dust MitePhase 2NCT01527188
Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model
A Phase 2 study testing 100 IR house dust mites allergen extract tablet, 300 IR house dust mites allergen extract tablet and 500 IR house dust mites allergen extract tablet in people with Allergic Rhinitis Due to House Dust Mite, run by Stallergenes Greer at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite
- What is being tested?
- 100 IR house dust mites allergen extract tablet, 300 IR house dust mites allergen extract tablet and 500 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
- 355 participants
- Where
- 1 siteCanada
- Study dates
- 8 Dec 2010to 19 Sep 2012
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- history of HDM rhinitis allergy for > 1 year
- sensitized to D. pteronyssinus and/or D. farinae
- RTSS >= 6 at least 2 time points during allergen challenge session
Who cannot join
- co sensitization to other allergen than HDM
- FEV1 < 80%
- Asthma GINA > 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model
The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Being tested
- 100 IR house dust mites allergen extract tablet, 300 IR house dust mites allergen extract tablet, 500 IR house dust mites allergen extract tablet, Placebo tablet
- Keywords
- HDM, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 IR house dust mites allergen extract tabletDrug
Also called Sublingual immunotherapy tablet
One sublingual tablet daily during 6 months
300 IR house dust mites allergen extract tabletDrug
Also called Sublingual immunotherapy tablet
One sublingual tablet daily during 6 months
500 IR house dust mites allergen extract tabletDrug
Also called Sublingual immunotherapy tablet
One sublingual tablet daily during 6 months
Placebo tabletDrug
Also called Sublingual placebo tablet
One sublingual tablet daily during 6 months
| Study group | Role | What they receive |
|---|---|---|
| 100 IR | Experimental | 100 IR house dust mites allergen extract tablet Receives: Drug: 100 IR house dust mites allergen extract tablet |
| 300 IR | Experimental | 300 IR house dust mites allergen extract tablet Receives: Drug: 300 IR house dust mites allergen extract tablet |
| 500 IR | Experimental | 500 IR house dust mites allergen extract tablet Receives: Drug: 500 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.
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge
The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC).
The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.
Measured: 6 months
Secondary outcomes (1)
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge
Change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the last two hours (2-4h) of the allergen challenge in the Environmental Exposure Chamber (EEC).
The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study start8 Dec 2010
- Primary completionMar 2012
- Study completion19 Sep 2012
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 House 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, FRCPC, Principal investigator, Cetero Research / PRACS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527188
- Sponsor's protocol ID
- VO67.10
- Status last verified
- Jan 2025
- First submitted
- 1 Feb 2012
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model
- ClinicalTrials.gov ID
- NCT01527188
- Acronym / sponsor ID
- VO67.10
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Keywords
- HDM, allergic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2010 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- 19 Sep 2012 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 4 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 effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100 IR | Experimental | Drug: 100 IR house dust mites allergen extract tablet100 IR house dust mites allergen extract tablet |
| 300 IR | Experimental | Drug: 300 IR house dust mites allergen extract tablet300 IR house dust mites allergen extract tablet |
| 500 IR | Experimental | Drug: 500 IR house dust mites allergen extract tablet500 IR house dust mites allergen extract tablet |
| Placebo | Placebo comparator | Drug: Placebo tabletPlacebo tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- history of HDM rhinitis allergy for > 1 year
- sensitized to D. pteronyssinus and/or D. farinae
- RTSS >= 6 at least 2 time points during allergen challenge session
Key exclusion criteria (3 listed)
- co sensitization to other allergen than HDM
- FEV1 < 80%
- Asthma GINA > 1
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 |
|---|---|---|
| 100 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 6 months | Drug | 100 IR |
| 300 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 6 months | Drug | 300 IR |
| 500 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 6 months | Drug | 500 IR |
| Placebo tabletAlso: Sublingual placebo tabletOne sublingual tablet daily during 6 months | Drug | Placebo |
Primary outcome
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge
Time frame: 6 months
The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC). The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.
1 secondary outcome
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 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.
Peter Couroux, MD, FRCPC principal investigator
Cetero Research / PRACS Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 100 IR house dust mites allergen extract tablet, 300 IR house dust mites allergen extract tablet and 500 IR house dust mites allergen extract tablet in people with Allergic Rhinitis Due to House Dust Mite, run by Stallergenes Greer at 1 site in Canada.
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 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 4 Feb 2025. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 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?
Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge (time frame: 6 months). 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 NCT01527188, 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 4 Feb 2025.