Allergic Rhinitis Due to House Dust MitePhase 1NCT01919554
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
A Phase 1 study testing 500 IR house dust mites allergen extract tablet, 1000 IR house dust mites allergen extract tablet and 1500 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 investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite
- What is being tested?
- 500 IR house dust mites allergen extract tablet, 1000 IR house dust mites allergen extract tablet and 1500 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
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 1
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent from patient and parent(s)/legal representative.
- Male or female patient from 12 to 17 years.
- Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
- Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
- Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
- Spirometry with best FEV1 > 80% of predicted FEV1.
Who cannot join
- Patient with a nasal or oral disease that could interfere with the safety assessments
- Patient has undergone recent nasal surgery
- Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
- Patient with partially controlled or uncontrolled asthma
- Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
- Female patient pregnant or breast-feeding/lactating.
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- Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
- patient with a history of anaphylaxis
- patient having participated in any clinical study within the 12 weeks before visit 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Being tested
- 500 IR house dust mites allergen extract tablet, 1000 IR house dust mites allergen extract tablet, 1500 IR house dust mites allergen extract tablet, Placebo tablet
- Keywords
- House Dust Mite Allergic Rhinitis, Phase I, House Dust Mite Allergen Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 IR house dust mites allergen extract tabletBiological
Also called Sublingual immunotherapy tablet
One sublingual tablet daily during 10 days
1000 IR house dust mites allergen extract tabletBiological
Also called Sublingual immunotherapy tablet
Two sublingual tablets daily during 10 days
1500 IR house dust mites allergen extract tabletBiological
Also called Sublingual immunotherapy tablet
Three sublingual tablets daily during 10 days
Placebo tabletBiological
Also called Sublingual placebo tablet
One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets
| Study group | Role | What they receive |
|---|---|---|
| 500 IR | Experimental | 500 IR house dust mites allergen extract tablet Receives: Biological: 500 IR house dust mites allergen extract tablet |
| 1000 IR | Experimental | 1000 IR house dust mites allergen extract tablet Receives: Biological: 1000 IR house dust mites allergen extract tablet |
| 1500 IR | Experimental | 1500 IR house dust mites allergen extract tablet Receives: Biological: 1500 IR house dust mites allergen extract tablet |
| Placebo | Placebo comparator | Placebo tablet Receives: Biological: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Measured: 10 dosing treatment days
Secondary outcomes (2)
Treatment Emergent Serious Adverse Events
Treatment emergent Serious Adverse Events
Measured: 10 dosing treatment days
Adverse Events Leading to Study Withdrawal
Incidence of adverse events leading to study withdrawal
Measured: 10 dosing treatment days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Piyush Patel, MD, Principal investigator, Inflamax Research Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919554
- Sponsor's protocol ID
- VO73.13
- Status last verified
- Dec 2015
- First submitted
- 2 Aug 2013
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01919554
- Acronym / sponsor ID
- VO73.13
- Conditions
- Allergic Rhinitis Due to House Dust Mite
- Keywords
- House Dust Mite Allergic Rhinitis, Phase I, House Dust Mite Allergen Extract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 17 Jan 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 investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
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 |
|---|---|---|
| 500 IR | Experimental | Biological: 500 IR house dust mites allergen extract tablet500 IR house dust mites allergen extract tablet |
| 1000 IR | Experimental | Biological: 1000 IR house dust mites allergen extract tablet1000 IR house dust mites allergen extract tablet |
| 1500 IR | Experimental | Biological: 1500 IR house dust mites allergen extract tablet1500 IR house dust mites allergen extract tablet |
| Placebo | Placebo comparator | Biological: Placebo tabletPlacebo tablet |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written informed consent from patient and parent(s)/legal representative.
- Male or female patient from 12 to 17 years.
- Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
- Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
- Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
Key exclusion criteria (11 listed)
- Patient with a nasal or oral disease that could interfere with the safety assessments
- Patient has undergone recent nasal surgery
- Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
- Patient with partially controlled or uncontrolled asthma
- Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
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 |
|---|---|---|
| 500 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily during 10 days | Biological | 500 IR |
| 1000 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletTwo sublingual tablets daily during 10 days | Biological | 1000 IR |
| 1500 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletThree sublingual tablets daily during 10 days | Biological | 1500 IR |
| Placebo tabletAlso: Sublingual placebo tabletOne, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets | Biological | Placebo |
Primary outcome
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Time frame: 10 dosing treatment days
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
2 secondary outcomes
Treatment Emergent Serious Adverse Events
Time frame: 10 dosing treatment days
Adverse Events Leading to Study Withdrawal
Time frame: 10 dosing treatment days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Piyush Patel, MD principal investigator
Inflamax Research Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 500 IR house dust mites allergen extract tablet, 1000 IR house dust mites allergen extract tablet and 1500 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 6 inclusion and 11 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 17 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Jan 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?
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events (time frame: 10 dosing treatment days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2025.