AllergyPhase 3NCT00660452
A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites
A Phase 3 study testing Staloral in people with Allergy, run by Stallergenes Greer at 1 site in China.
Trial summary
A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Allergy
- What is being tested?
- Staloral
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 3
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female outpatients aged 16 to 50 years (inclusive).
- House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
- Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
- Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day.
Who cannot join
- Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
- Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
- FEV1 < 70% of predicted value at Visit 1.
- Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Chinese Asthmatic Patients Allergic to House-dust Mites
A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.
- Conditions
- Allergy
- Being tested
- Staloral
- Keywords
- Allergy, SLIT, Asthma, House Dust Mites
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaloralDrug
Sublingual immunotherapy with Staloral dust mites solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 360 active patients with house dust mites related asthma with or without allergic rhinitis Receives: Drug: Staloral |
| 2 | Placebo comparator | 180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis. Receives: Drug: Staloral |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo
Measured: September 2009
Secondary outcomes (1)
Daily dose of steroids at the endpoint Number of asthma exacerbations Asthma Control Questionnaire(ACQ)score Asthma Quality of Life Questionnaire (AQLQ) score Lung Function Parameters ( FEV1; FEF 25-75 %; PEF) Allergic rhinitis g
Measured: September 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jia YIN, Pr., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660452
- Sponsor's protocol ID
- VO55.06 CHIN
- Status last verified
- Oct 2011
- First submitted
- 15 Apr 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
PubMed 32926419Devillier P, Fadel R, de Beaumont O. House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. Allergy. 2016 Feb;71(2):249-57. doi: 10.1111/all.12791. Epub 2015 Nov 6.
PubMed 26465232Wang L, Yin J, Fadel R, Montagut A, de Beaumont O, Devillier P. House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma. Allergy. 2014 Sep;69(9):1181-8. doi: 10.1111/all.12188. Epub 2014 Jul 24.
PubMed 25056584
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Chinese Asthmatic Patients Allergic to House-dust Mites
- ClinicalTrials.gov ID
- NCT00660452
- Acronym / sponsor ID
- VO55.06 CHIN
- Conditions
- Allergy
- Keywords
- Allergy, SLIT, Asthma, House Dust Mites
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Apr 2008 (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.
A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Staloral360 active patients with house dust mites related asthma with or without allergic rhinitis |
| 2 | Placebo comparator | Drug: Staloral180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female outpatients aged 16 to 50 years (inclusive).
- House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
- Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
- Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day.
Key exclusion criteria (5 listed)
- Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
- Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
- FEV1 < 70% of predicted value at Visit 1.
- Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
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 |
|---|---|---|
| StaloralSublingual immunotherapy with Staloral dust mites solution | Drug | 1, 2 |
Primary outcome
determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo
Time frame: September 2009
1 secondary outcome
Daily dose of steroids at the endpoint Number of asthma exacerbations Asthma Control Questionnaire(ACQ)score Asthma Quality of Life Questionnaire (AQLQ) score Lung Function Parameters ( FEV1; FEF 25-75 %; PEF) Allergic rhinitis g
Time frame: September 2009
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 12 Oct 2011.
- Derived from this study: PubMed 32926419Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
- Derived from this study: PubMed 26465232Devillier P, Fadel R, de Beaumont O. House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. Allergy. 2016 Feb;71(2):249-57. doi: 10.1111/all.12791. Epub 2015 Nov 6.
- Derived from this study: PubMed 25056584Wang L, Yin J, Fadel R, Montagut A, de Beaumont O, Devillier P. House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma. Allergy. 2014 Sep;69(9):1181-8. doi: 10.1111/all.12188. Epub 2014 Jul 24.
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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.
Jia YIN, Pr. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Staloral in people with Allergy, run by Stallergenes Greer at 1 site in China.
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 4 inclusion and 5 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 12 Oct 2011. 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 China. 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 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?
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?
determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (time frame: September 2009). 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 NCT00660452, 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 12 Oct 2011.