Allergic RhinitisPhase 2/3NCT00674700
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis
A Phase 2/3 study testing 300 IR house dust mites allergen extract tablet and 500 IR house dust mites allergen extract tablet in people with Allergic Rhinitis, run by Stallergenes Greer.
Trial summary
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- 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
- 509 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Feb 2010
- Phase
- Phase 2/3
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female outpatients aged 18 to 50 years (inclusive).
- Patients who have been informed of the nature and aims of the study and have given their written consent
- Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
- Female patients of childbearing potential are eligible
- Negative urine pregnancy test on female patients of childbearing potential.
- House dust mite-related allergic rhinitis for at least 1 year.
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- Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level ≥ 0.7 kU/L).
- Baseline ARTSS > 5 (after completion of the 7-day daily record card).
- Patients who are willing to comply with the protocol.
- Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.
Who cannot join
- Whatever the considered allergens, co-sensitisation leading to 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).
- Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
- Patients sensitised to cat or dog allergens and living with these animals at home.
- Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1).
- Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1.
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- Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2.
- FEV1 < 80% of predicted value at Visit 1.
- Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.
- Patients at risk of non-compliance.
- Participation in any clinical study within the 12 weeks before Visit 1.
- Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
- Any change in environmental measures for allergen avoidance during the study.
About this study
Official title: A Randomized, DBPC, Multi-national Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis
The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
Read the detailed description
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.
In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.
After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
- Conditions
- Allergic Rhinitis
- Being tested
- 300 IR house dust mites allergen extract tablet, 500 IR house dust mites allergen extract tablet, Placebo tablet
- Keywords
- House dust mites allergy
- Medical subject headings
- Rhinitis, Allergic
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 Sublingual immunotherapy tablet
One sublingual tablet daily for one year
500 IR house dust mites allergen extract tabletDrug
Also called Sublingual immunotherapy 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 |
| 500 IR | Active comparator | 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.
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).
It ranges from 0 to 12, the higher the score the more severe the rhinitis.
Measured: Last 3 months of Year 1
Secondary outcomes (1)
Average Rhinitis Total Symptom Score (ARTSS)
The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.
Measured: Last 3 months of Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionFeb 2010
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 (3)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl-Christian BERGMANN, MD, Study chair, Allergie-Centrum-Charité / ECARF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674700
- Sponsor's protocol ID
- VO57.07
- Status last verified
- Apr 2016
- First submitted
- 6 May 2008
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bergmann KC, Demoly P, Worm M, Fokkens WJ, Carrillo T, Tabar AI, Nguyen H, Montagut A, Zeldin RK. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.
PubMed 24388010Worm 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 39035788Baron-Bodo V, Batard T, Nguyen H, Frereux M, Horiot S, Harwanegg C, Bergmann KC, de Beaumont O, Moingeon P. Absence of IgE neosensitization in house dust mite allergic patients following sublingual immunotherapy. Clin Exp Allergy. 2012 Oct;42(10):1510-8. doi: 10.1111/j.1365-2222.2012.04044.x.
PubMed 22994348
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, DBPC, Multi-national Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00674700
- Acronym / sponsor ID
- VO57.07
- Conditions
- Allergic Rhinitis
- Keywords
- House dust mites allergy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 19 May 2016
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 two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
Detailed description
Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.
In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.
After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 300 IR | Active comparator | Drug: 300 IR house dust mites allergen extract tablet300 IR house dust mites allergen extract tablet |
| 500 IR | Active comparator | 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 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female outpatients aged 18 to 50 years (inclusive).
- Patients who have been informed of the nature and aims of the study and have given their written consent
- Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
- Female patients of childbearing potential are eligible
- Negative urine pregnancy test on female patients of childbearing potential.
Key exclusion criteria (13 listed)
- Whatever the considered allergens, co-sensitisation leading to 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).
- Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
- Patients sensitised to cat or dog allergens and living with these animals at home.
- Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 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 |
|---|---|---|
| 300 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily for one year | Drug | 300 IR |
| 500 IR house dust mites allergen extract tabletAlso: Sublingual immunotherapy tabletOne sublingual tablet daily for one year | Drug | 500 IR |
| Placebo tabletAlso: Sublingual placebo tabletOne sublingual tablet daily for one year | Drug | Placebo |
Primary outcome
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
Time frame: Last 3 months of Year 1
The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12, the higher the score the more severe the rhinitis.
1 secondary outcome
Average Rhinitis Total Symptom Score (ARTSS)
Time frame: Last 3 months of Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24388010Bergmann KC, Demoly P, Worm M, Fokkens WJ, Carrillo T, Tabar AI, Nguyen H, Montagut A, Zeldin RK. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.
- 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.
- Derived from this study: PubMed 22994348Baron-Bodo V, Batard T, Nguyen H, Frereux M, Horiot S, Harwanegg C, Bergmann KC, de Beaumont O, Moingeon P. Absence of IgE neosensitization in house dust mite allergic patients following sublingual immunotherapy. Clin Exp Allergy. 2012 Oct;42(10):1510-8. doi: 10.1111/j.1365-2222.2012.04044.x.
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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.
Karl-Christian BERGMANN, MD study chair
Allergie-Centrum-Charité / ECARF
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 300 IR house dust mites allergen extract tablet and 500 IR house dust mites allergen extract tablet in people with Allergic Rhinitis, 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 10 inclusion and 13 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 19 May 2016. 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 combined 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.
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 19 May 2016). 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 (AAdSS) During the Year 1 Primary Period (time frame: Last 3 months of Year 1). 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 NCT00674700, which also lists 3 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 19 May 2016.