Allergic RhinitisPhase 4NCT00698594
Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis
A Phase 4 study testing sublingual allergen extract in people with Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- sublingual allergen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2008to Mar 2011
- 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
- Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study
Who cannot join
- Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
- Allergic rhinitis hospitalisation during the 3 months before the first visit.
- Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
- Excluded medications were systemic corticosteroids.
- Patients who were receiving immunotherapy were also excluded.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Łódź Voivodeship
About this study
Official title: Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen
The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
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 the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children.
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
- Conditions
- Allergic Rhinitis
- Being tested
- sublingual allergen extract, placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual allergen extractBiological
Also called Staloral 300 IR, Stallergenes, France
Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group
sublingual allergen extractBiological
Also called Staloral 300 IR, Stallergenes, France
Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group
placeboBiological
Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group Receives: Biological: sublingual allergen extract |
| 2 | Active comparator | Group of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group Receives: Biological: sublingual allergen extract |
| 3 | Placebo comparator | Group of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).
Measured: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.
Secondary outcomes (2)
Change of percent of regulatory lymphocytes in the peripheral blood.
Measured: at baseline and at the end of the second season (22 months interval)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.
Measured: at the end of the first and second season of the study (12 months interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
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, Prof., Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698594
- Sponsor's protocol ID
- RNN/98/08/KE
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2008
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness and Safety of Sublingual Immunotherapy in Children With Allergic Rhinitis Allergic to Grass Pollen
- ClinicalTrials.gov ID
- NCT00698594
- Acronym / sponsor ID
- RNN/98/08/KE
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Jun 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.
The purpose of the trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
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 the possibility of avoiding injection this therapy allows to have better relationship with patient, and reduce the costs of therapy thanks to reducing the numbers of visits in out-patient clinic.However efficacy and safety of sublingual immunotherapy are still important issues, especially in children.
The purpose of trial is to compare the efficacy and safety of sublingual seasonal and annual immunotherapy in children with allergic rhinitis allergic to grass pollens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: sublingual allergen extractGroup of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group |
| 2 | Active comparator | Biological: sublingual allergen extractGroup of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group |
| 3 | Placebo comparator | Biological: placeboGroup of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with seasonal allergic rhinitis, allergic to grass pollens, first diagnosed at least 2 years before inclusion into the study
Key exclusion criteria (5 listed)
- Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
- Allergic rhinitis hospitalisation during the 3 months before the first visit.
- Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
- Excluded medications were systemic corticosteroids.
- Patients who were receiving immunotherapy were also excluded.
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 allergen extractAlso: Staloral 300 IR, Stallergenes, FranceGroup of children with allergic rhinitis 6-18 years old. receiving seasonally grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - seasonal SLIT group | Biological | 1 |
| sublingual allergen extractAlso: Staloral 300 IR, Stallergenes, FranceGroup of children with allergic rhinitis 6-18 years old receiving yearly grass pollens sublingual allergen extract (Staloral 300 IR, Stallergenes, France) (n=20) - yearly SLIT group | Biological | 2 |
| placeboGroup of children with allergic rhinitis 6-18 years old receiving placebo in sublingual applicator (Staloral 300 IR, Stallergenes, France) (n=20) - placebo group | Biological | 3 |
Primary outcome
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire)
Time frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 months.
Visit 2 (6 months after starting the study), visit 3 (9 months after starting the study), visit 4 (12 months after starting the study), visit 5 (18 months after starting the study), visit 6 (21 months after starting the study), visit 7 (24 months after starting the study).
2 secondary outcomes
Change of percent of regulatory lymphocytes in the peripheral blood.
Time frame: at baseline and at the end of the second season (22 months interval)
non-specific bronchial hyperreactivity with methacholine (PC20M), specific nasal provocation test.
Time frame: at the end of the first and second season of the study (12 months interval)
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 22 Aug 2011.
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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, Prof. principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
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 allergen extract in people with 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 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 22 Aug 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 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?
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?
Clinical symptoms of allergic rhinitis (Pediatric Quality of Life Questionnaire) (time frame: Following visits after starting the study: at 6 months, 9 months, 12 months, 18 months, 21 months, 24 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 22 Aug 2011.