AsthmaPhase 1NCT01608243
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
A Phase 1 study testing SLIT tablets of house dust mite allergen extracts in people with Asthma and House Dust Mite Allergy, run by Stallergenes Greer at 1 site in France.
Trial summary
The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma, House Dust Mite Allergy
- What is being tested?
- SLIT tablets of house dust mite allergen extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent.
- Male or female patient from 18 to 50 years.
- Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
- Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
- Stable asthma treatments.
- Spirometry with best FEV1 > 70% of the predicted value.
- Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
- Asthma Control Test™ (ACT) score ≥ 20.
Who cannot join
- Current smoker or former smoker with > 10 pack/year history.
- Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
- 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.
- Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
- Female patient pregnant or breast-feeding/lactating.
- Female patient of childbearing potential not using a medically accepted contraceptive method.
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- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Patient who received allergen immunotherapy for HDM in the last 10 years.
- Ongoing treatment by immunotherapy with another allergen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.
- Conditions
- Asthma, House Dust Mite Allergy
- Being tested
- SLIT tablets of house dust mite allergen extracts, Matching placebo
- Medical subject headings
- Asthma, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLIT tablets of house dust mite allergen extractsBiological
10 dosing days
Matching placeboBiological
10 dosing days
| Study group | Role | What they receive |
|---|---|---|
| SLIT tablets of HDM allergen extracts | Experimental | Not described Receives: Biological: SLIT tablets of house dust mite allergen extracts |
| Placebo | Placebo comparator | Not described Receives: Biological: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
Measured: 10 dosing days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Demoly, MD, Principal investigator, CHU Arnaud de Villeneuve, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608243
- Sponsor's protocol ID
- VO71.11
- Status last verified
- Jun 2014
- First submitted
- 25 May 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
- ClinicalTrials.gov ID
- NCT01608243
- Acronym / sponsor ID
- VO71.11
- Conditions
- Asthma, House Dust Mite Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 May 2012 (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 purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLIT tablets of HDM allergen extracts | Experimental | Biological: SLIT tablets of house dust mite allergen extracts |
| Placebo | Placebo comparator | Biological: Matching placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Written informed consent.
- Male or female patient from 18 to 50 years.
- Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
- Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
- Stable asthma treatments.
Key exclusion criteria (9 listed)
- Current smoker or former smoker with > 10 pack/year history.
- Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
- 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.
- Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
- Female patient pregnant or breast-feeding/lactating.
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 |
|---|---|---|
| SLIT tablets of house dust mite allergen extracts10 dosing days | Biological | SLIT tablets of HDM allergen extracts |
| Matching placebo10 dosing days | Biological | Placebo |
Primary outcome
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
Time frame: 10 dosing days
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 1 Jul 2014.
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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.
Pascal Demoly, MD principal investigator
CHU Arnaud de Villeneuve, Montpellier, France
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 SLIT tablets of house dust mite allergen extracts in people with Asthma and House Dust Mite Allergy, run by Stallergenes Greer 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 8 inclusion and 9 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 1 Jul 2014. 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 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?
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?
Safety, tolerability as indicated by adverse events and safety laboratory evaluation (time frame: 10 dosing 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 1 Jul 2014.