Bronchial AsthmaPhase 4NCT01052610
Assessment of Sublingual Immunotherapy in Children Allergic to House Dust Mites
A Phase 4 study testing sublingual house dust mites allergen extract in people with Bronchial Asthma and Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchial Asthma, Allergic Rhinitis
- What is being tested?
- sublingual house dust mites allergen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2010to Sep 2013
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study
Who cannot join
- active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
- hospitalisation due to asthma exacerbation during the 3 months before the first visit
- known contraindications of SIT according to the EAACI
- previous allergen immunotherapy
- use of systemic corticosteroids
- other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or mental diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy
Lodz, 93-513
Monika Bobrowska-Korzeniowska, MD, PhD, 426895972, alergol@kopernik.lodz.pl
Monika Bobrowska-Korzeniowska, MD, PhD
About this study
Official title: Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites
The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
Read the detailed description
Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
- Conditions
- Bronchial Asthma, Allergic Rhinitis
- Being tested
- sublingual house dust mites allergen extract, placebo in sublingual applicator
- Keywords
- SLIT, bronchial asthma, allergic rhinitis
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual house dust mites allergen extractDrug
Staloral 300 IR, Stallergenes, France
placebo in sublingual applicatorDrug
placebo for Staloral 300 IR, Stallergenes, France
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract Receives: Drug: sublingual house dust mites allergen extract |
| Placebo group | Placebo comparator | Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator Receives: Drug: placebo in sublingual applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication
Measured: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Secondary outcomes (3)
Change of percent of regulatory lymphocytes in peripheral blood
Measured: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
assessment of inflammatory markers in exhaled breath condensate and FeNO
Measured: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test
Measured: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Iwona Stelmach, MD, PhD, Prof, Study chair, Department of Pediatrics and Allergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052610
- Sponsor's protocol ID
- 502-12-760, 503-2056-1
- Status last verified
- Feb 2013
- First submitted
- 12 Jan 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effectiveness and Safety of Annual Sublingual Immunotherapy in Children With Bronchial Asthma and/or Allergic Rhinitis Allergic to House Dust Mites
- ClinicalTrials.gov ID
- NCT01052610
- Acronym / sponsor ID
- 502-12-760, 503-2056-1
- Conditions
- Bronchial Asthma, Allergic Rhinitis
- Keywords
- SLIT, bronchial asthma, allergic rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 20 Jan 2010 (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 the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
Detailed description
Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: sublingual house dust mites allergen extractGroup of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract |
| Placebo group | Placebo comparator | Drug: placebo in sublingual applicatorGroup of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with bronchial asthma and/or allergic rhinitis allergic to house dust mites first diagnosed at least 2 years before the study
Key exclusion criteria (6 listed)
- active respiratory tract infection requiring antibiotic treatment within 4 weeks before the study
- hospitalisation due to asthma exacerbation during the 3 months before the first visit
- known contraindications of SIT according to the EAACI
- previous allergen immunotherapy
- use of systemic corticosteroids
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 |
|---|---|---|
| sublingual house dust mites allergen extractStaloral 300 IR, Stallergenes, France | Drug | Active group |
| placebo in sublingual applicatorplacebo for Staloral 300 IR, Stallergenes, France | Drug | Placebo group |
Primary outcome
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
3 secondary outcomes
Change of percent of regulatory lymphocytes in peripheral blood
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
assessment of inflammatory markers in exhaled breath condensate and FeNO
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test
Time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Iwona Stelmach, MD, PhD, Prof study chair
Department of Pediatrics and Allergy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sublingual house dust mites allergen extract in people with Bronchial Asthma and Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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 Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iwona Stelmach, MD, PhD, Prof (+48426895972, alergol@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms of asthma and allergic rhinitis and use of rescue medication (time frame: Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT)). 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 7 Feb 2013.