AsthmaPhase 2NCT01930461
Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma
A Phase 2 study testing SLIT tablets of HDM allergen extracts, 3 different doses (A), SLIT tablets of HDM allergen extracts, 3 different doses (B) and SLIT tablets of HDM allergen extracts, 3 different doses (C) in people with Asthma and House Dust Mite Allergy, run by Stallergenes Greer at 5 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo 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 HDM allergen extracts, 3 different doses (A), SLIT tablets of HDM allergen extracts, 3 different doses (B) and SLIT tablets of HDM allergen extracts, 3 different doses (C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Sep 2013to Aug 2015
- Phase
- Phase 2
- 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 from 18 to 50 years of age.
- Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
- Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
- Stable asthma therapies.
- Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
- Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
- Asthma Control Test™ (ACT) score ≤ 19.
Who cannot join
- Former smoker with > 10 pack year history or current smoker.
- Patient with a urine level of cotinine ≥ 500 ng/mL.
- Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
- Patient who received allergen immunotherapy for HDM within the past 10 years.
- Ongoing immunotherapy for an aeroallergen other than house dust mite.
- Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
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- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Pregnant women or breast-feeding/lactating.
- Women with childbearing potential who are not using a medically accepted birth control method.
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France2 sites
CHU Arnaud de Villeneuve
Montpellier, 34295
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Poland2 sites
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, 90-153
Majorek-Olechowska Bernadetta
Tarnów, 33-100
Germany1 site
Universitätsmedizin Berlin - Allergie-Centrum-Charité
Berlin, 10117
About this study
Official title: A Dose Ranging Study Investigating the Efficacy and Safety 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 efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.
- Conditions
- Asthma, House Dust Mite Allergy
- Being tested
- SLIT tablets of HDM allergen extracts, 3 different doses (A), SLIT tablets of HDM allergen extracts, 3 different doses (B), SLIT tablets of HDM allergen extracts, 3 different doses (C), Placebo matching the SLIT tablets of HDM allergen extracts
- 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 HDM allergen extracts, 3 different doses (A)Biological
Also called Sublingual immunotherapy tablet
Two sublingual tablets daily for 13 months
SLIT tablets of HDM allergen extracts, 3 different doses (B)Biological
Also called Sublingual immunotherapy tablet
Two sublingual tablets daily for 13 months
SLIT tablets of HDM allergen extracts, 3 different doses (C)Biological
Also called Sublingual immunotherapy tablet
Two sublingual tablets daily for 13 months
Placebo matching the SLIT tablets of HDM allergen extractsBiological
Also called Sublingual placebo tablet
Two sublingual tablets daily for 13 months
| Study group | Role | What they receive |
|---|---|---|
| SLIT (A) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (A) Receives: Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A) |
| SLIT (B) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (B) Receives: Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B) |
| SLIT (C) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (C) Receives: Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C) |
| Placebo | Placebo comparator | Placebo matching the SLIT tablets of HDM allergen extracts Receives: Biological: Placebo matching the SLIT tablets of HDM allergen extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the Asthma control test (ACT) score
Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma
Measured: 13 months
Secondary outcomes (1)
Number and percentage of subjects with treatment-emergent AEs
Measured: Measured during 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionAug 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Demoly, MD, Principal investigator, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930461
- Sponsor's protocol ID
- VO72.12
- Status last verified
- Dec 2015
- First submitted
- 16 Aug 2013
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
- ClinicalTrials.gov ID
- NCT01930461
- Acronym / sponsor ID
- VO72.12
- Conditions
- Asthma, House Dust Mite Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Aug 2013 (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 efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo 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
- 4
| Arm | Type | Receives |
|---|---|---|
| SLIT (A) | Experimental | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A)SLIT tablets of HDM allergen extracts, 3 different doses (A) |
| SLIT (B) | Experimental | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B)SLIT tablets of HDM allergen extracts, 3 different doses (B) |
| SLIT (C) | Experimental | Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C)SLIT tablets of HDM allergen extracts, 3 different doses (C) |
| Placebo | Placebo comparator | Biological: Placebo matching the SLIT tablets of HDM allergen extractsPlacebo matching the SLIT tablets of HDM allergen extracts |
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 from 18 to 50 years of age.
- Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
- Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
- Stable asthma therapies.
Key exclusion criteria (10 listed)
- Former smoker with > 10 pack year history or current smoker.
- Patient with a urine level of cotinine ≥ 500 ng/mL.
- Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
- Patient who received allergen immunotherapy for HDM within the past 10 years.
- Ongoing immunotherapy for an aeroallergen other than house dust mite.
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 HDM allergen extracts, 3 different doses (A)Also: Sublingual immunotherapy tabletTwo sublingual tablets daily for 13 months | Biological | SLIT (A) |
| SLIT tablets of HDM allergen extracts, 3 different doses (B)Also: Sublingual immunotherapy tabletTwo sublingual tablets daily for 13 months | Biological | SLIT (B) |
| SLIT tablets of HDM allergen extracts, 3 different doses (C)Also: Sublingual immunotherapy tabletTwo sublingual tablets daily for 13 months | Biological | SLIT (C) |
| Placebo matching the SLIT tablets of HDM allergen extractsAlso: Sublingual placebo tabletTwo sublingual tablets daily for 13 months | Biological | Placebo |
Primary outcome
Effect on the Asthma control test (ACT) score
Time frame: 13 months
Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma
1 secondary outcome
Number and percentage of subjects with treatment-emergent AEs
Time frame: Measured during 13 months
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 18 Dec 2015.
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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
Montpellier, France
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLIT tablets of HDM allergen extracts, 3 different doses (A), SLIT tablets of HDM allergen extracts, 3 different doses (B) and SLIT tablets of HDM allergen extracts, 3 different doses (C) in people with Asthma and House Dust Mite Allergy, run by Stallergenes Greer at 5 sites in 3 countries.
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 10 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 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Poland, Germany. 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?
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?
Effect on the Asthma control test (ACT) score (time frame: 13 months). 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 18 Dec 2015.