Allergic RhinitisPhase 4NCT01605760
House Dust Mite SLIT in Elderly Patients
A Phase 4 study testing immunotherapy Staloral in people with Allergic Rhinitis, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- immunotherapy Staloral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2008to Mar 2012
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study
Who cannot join
- Patients with any of the following characteristics were excluded:
- hypersensitivity to other allergens,
- non-allergic rhinitis (especially senile or vasomotor rhinitis) or
- severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.
- Conditions
- Allergic Rhinitis
- Being tested
- immunotherapy Staloral
- Keywords
- immunotherapy, elderly
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapy StaloralDrug
Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
| Study group | Role | What they receive |
|---|---|---|
| non immunotherapy treatment | No intervention | Not described Receives: Drug: immunotherapy Staloral |
| sublingual immunotherapy course | Active comparator | Not described Receives: Drug: immunotherapy Staloral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event during immunotherapy
Safety assessment of sublingual immunotherapy on the basis of the monitoring clinical adverse events during treatment by the use of a patient diary and medical examination.
Measured: three year
Secondary outcomes (1)
Change from baseline of nasal symptoms after immunotherapy
Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Bozek, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605760
- Sponsor's protocol ID
- 657898/2008
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012.
PubMed 28668244Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.
PubMed 23331565
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
- ClinicalTrials.gov ID
- NCT01605760
- Acronym / sponsor ID
- 657898/2008
- Conditions
- Allergic Rhinitis
- Keywords
- immunotherapy, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 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 safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non immunotherapy treatment | No intervention | Drug: immunotherapy Staloral |
| sublingual immunotherapy course | Active comparator | Drug: immunotherapy Staloral |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study
Key exclusion criteria (4 listed)
- Patients with any of the following characteristics were 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 |
|---|---|---|
| immunotherapy StaloralStaloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months). | Drug | non immunotherapy treatment, sublingual immunotherapy course |
Primary outcome
Number of participants with adverse event during immunotherapy
Time frame: three year
Safety assessment of sublingual immunotherapy on the basis of the monitoring clinical adverse events during treatment by the use of a patient diary and medical examination.
1 secondary outcome
Change from baseline of nasal symptoms after immunotherapy
Time frame: three year
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 25 May 2012.
- Derived from this study: PubMed 28668244Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012.
- Derived from this study: PubMed 23331565Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 immunotherapy Staloral in people with Allergic Rhinitis, run by Medical University of Silesia 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 4 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 25 May 2012. 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. 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?
Number of participants with adverse event during immunotherapy (time frame: three year). 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 NCT01605760, which also lists 2 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 25 May 2012.