Allergen Immunotherapy in Elderly PatientsPhase 3HDMeldNCT03209245
House Dust Mite Injection Immunotherapy in Elderly Patients.
A Phase 3 study testing Purethal Mites, monitoring of allergen specific IgE and monitoring of allergen specific IgG4 in people with Allergen Immunotherapy in Elderly Patients, run by Medical University of Silesia.
Trial summary
Background. Immunotherapy in elderly patients is controversial, and there is still not much evidences supporting this treatment's safety and efficacy in this population. This study was performed to evaluate the safety and efficacy of specific injection immunotherapy for house dust mite allergens in patients over 65… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergen Immunotherapy in Elderly Patients
- What is being tested?
- Purethal Mites, monitoring of allergen specific IgE and monitoring of allergen specific IgG4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2014to 15 Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects had moderate or severe intermittent allergic rhinitis and fulfilled the Allergic Rhinitis and its Impact on Asthma (ARIA) criterion
- the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens.
Who cannot join
- Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens were excluded from the study. Additionally, patients with any of the following characteristics were also excluded: diagnosis of bronchial asthma, non-allergic rhinitis and severe non-stable diseases. Patients with other nasal problems, such as chronic nasal obstruction, reduced olfaction, bacterial colonization, and chronic sinusitis, were diagnosed based on a CT scan and nasal endoscopy were excluded. Subjects with other chronic or acute clinical disorders or with a history of respiratory tract infections within four weeks of the study initiation were also excluded.
About this study
Official title: House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.
Background. Immunotherapy in elderly patients is controversial, and there is still not much evidences supporting this treatment's safety and efficacy in this population. This study was performed to evaluate the safety and efficacy of specific injection immunotherapy for house dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means in the label in comparison to placebo.
Materials and methods. The study with double blind, placebo controlled trial was conducted in one centre. Fifty eight elderly patients with house dust mites allergy and AR were individually randomized in comparable numbers to one of two parallel groups: two years perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der p1 and Der p2 were monitoring.
Read the detailed description
The aim of this study was to assess the safety and efficacy of injection AIT for HDM allergens in elderly patients with allergic rhinitis and a confirmed HDM allergy. The study with double blind, placebo controlled trial was conducted in one centre. A total of 92 patients ranging from 65 to 73 years of age were recruited from the outpatient allergy clinic to assess their eligibility for inclusion in the study. First, there was a need for pre screening approximately 157 patients with inhalant allergies and the right age. Additionally, the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens. Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens (including other pollens) were excluded from the study. A careful examination of the eyes, ears, nose, and throat was performed on all patients. The severity of perennial allergic rhinitis (AR) was assessed using the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. The patients were randomly selected to receive PURETHAL Mites (20,000 AUeq/ml, HAL Allergy BV, Leiden, The Netherlands, containing major allergen equivalents of 14.0 μg/ml group 1, and 20.0 μg/ml group 2, measured by ELISA in the extract prior to modification and adsorption on aluminium hydroxide) or a placebo (Figure 1). The recruitment period was limited to three months (April-June). Purethal Mites were administered as perennial therapy using the following regimen: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months.
- Being tested
- Purethal Mites, placebo injection, monitoring of allergen specific IgE, monitoring of allergen specific IgG4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purethal MitesBiological
perennial allergren specific immunotherapy during 24 months
placebo injectionOther
perrenial injection wich were administered in same protocol as Purethal
monitoring of allergen specific IgEDiagnostic test
measurement the serum specific IgE at the start and at the end of trial
monitoring of allergen specific IgG4Diagnostic test
measurement the serum specific IgG4 at the start and at the end of trial
| Study group | Role | What they receive |
|---|---|---|
| Active AIT group | Active comparator | Injection immunotherapy with Purethal Mites were administered as perennial therapy using the following regimen of injections: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months.
monitoring of allergen specific IgE monitoring of allergen specific IgG4 Receives: Biological: Purethal Mites; Diagnostic Test: monitoring of allergen specific IgE; Diagnostic Test: monitoring of allergen specific IgG4 |
| non-active, placebo treatment | Placebo comparator | symptomatic treatment with concomitant use of placebo injection monitoring of allergen specific IgE monitoring of allergen specific IgG4 Receives: Other: placebo injection; Diagnostic Test: monitoring of allergen specific IgE; Diagnostic Test: monitoring of allergen specific IgG4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the change from baseline in the mean AAdSS score difference in comparison to placebo.
Symptoms and medication score were presented as the average adjusted symptom score (AAdSS): score result with standard deviation
Measured: baseline and 24 months
Secondary outcomes (1)
Patients' quality of life was evaluated with the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
fill the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - score result
Measured: baseline, after 12 months and 24 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start10 Apr 2014
- Primary completion20 Jun 2016
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergen Immunotherapy in Elderly PatientsStudies 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
- Model description
- Treatment of AIT- active group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 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
- NCT03209245
- Sponsor's protocol ID
- HAB605060182
- Acronym
- HDMeld
- Status last verified
- Jul 2017
- First submitted
- 29 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bozek A, Kolodziejczyk K, Kozlowska R, Canonica GW. Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial. Clin Transl Allergy. 2017 Dec 1;7:43. doi: 10.1186/s13601-017-0180-9. eCollection 2017.
PubMed 29214012
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT03209245
- Acronym / sponsor ID
- HDMeld / HAB605060182
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 6 Jul 2017 (actual)
- 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.
Background. Immunotherapy in elderly patients is controversial, and there is still not much evidences supporting this treatment's safety and efficacy in this population. This study was performed to evaluate the safety and efficacy of specific injection immunotherapy for house dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means in the label in comparison to placebo.
Materials and methods. The study with double blind, placebo controlled trial was conducted in one centre. Fifty eight elderly patients with house dust mites allergy and AR were individually randomized in comparable numbers to one of two parallel groups: two years perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der p1 and Der p2 were monitoring.
Detailed description
The aim of this study was to assess the safety and efficacy of injection AIT for HDM allergens in elderly patients with allergic rhinitis and a confirmed HDM allergy. The study with double blind, placebo controlled trial was conducted in one centre. A total of 92 patients ranging from 65 to 73 years of age were recruited from the outpatient allergy clinic to assess their eligibility for inclusion in the study. First, there was a need for pre screening approximately 157 patients with inhalant allergies and the right age. Additionally, the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens. Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens (including other pollens) were excluded from the study. A careful examination of the eyes, ears, nose, and throat was performed on all patients. The severity of perennial allergic rhinitis (AR) was assessed using the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. The patients were randomly selected to receive PURETHAL Mites (20,000 AUeq/ml, HAL Allergy BV, Leiden, The Netherlands, containing major allergen equivalents of 14.0 μg/ml group 1, and 20.0 μg/ml group 2, measured by ELISA in the extract prior to modification and adsorption on aluminium hydroxide) or a placebo (Figure 1). The recruitment period was limited to three months (April-June). Purethal Mites were administered as perennial therapy using the following regimen: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Treatment of AIT- active group
| Arm | Type | Receives |
|---|---|---|
| Active AIT group | Active comparator | Biological: Purethal Mites, Diagnostic Test: monitoring of allergen specific IgE, Diagnostic Test: monitoring of allergen specific IgG4Injection immunotherapy with Purethal Mites were administered as perennial therapy using the following regimen of injections: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months. monitoring of allergen specific IgE monitoring of allergen specific IgG4 |
| non-active, placebo treatment | Placebo comparator | Other: placebo injection, Diagnostic Test: monitoring of allergen specific IgE, Diagnostic Test: monitoring of allergen specific IgG4symptomatic treatment with concomitant use of placebo injection monitoring of allergen specific IgE monitoring of allergen specific IgG4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subjects had moderate or severe intermittent allergic rhinitis and fulfilled the Allergic Rhinitis and its Impact on Asthma (ARIA) criterion
- the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens.
Key exclusion criteria (1 listed)
- Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens were excluded from the study. Additionally, patients with any of the following characteristics were also excluded: diagnosis of bronchial asthma, non-allergic rhinitis and severe non-stable diseases. Patients with other nasal problems, such as chronic nasal obstruction, reduced olfaction, bacterial colonization, and chronic sinusitis, were diagnosed based on a CT scan and nasal endoscopy were excluded. Subjects with other chronic or acute clinical disorders or with a history of respiratory tract infections within four weeks of the study initiation 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 |
|---|---|---|
| Purethal Mitesperennial allergren specific immunotherapy during 24 months | Biological | Active AIT group |
| placebo injectionperrenial injection wich were administered in same protocol as Purethal | Other | non-active, placebo treatment |
| monitoring of allergen specific IgEmeasurement the serum specific IgE at the start and at the end of trial | Diagnostic test | Active AIT group, non-active, placebo treatment |
| monitoring of allergen specific IgG4measurement the serum specific IgG4 at the start and at the end of trial | Diagnostic test | Active AIT group, non-active, placebo treatment |
Primary outcome
The primary endpoint was the change from baseline in the mean AAdSS score difference in comparison to placebo.
Time frame: baseline and 24 months
Symptoms and medication score were presented as the average adjusted symptom score (AAdSS): score result with standard deviation
1 secondary outcome
Patients' quality of life was evaluated with the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Time frame: baseline, after 12 months and 24 months of study
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 6 Jul 2017.
- Derived from this study: PubMed 29214012Bozek A, Kolodziejczyk K, Kozlowska R, Canonica GW. Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial. Clin Transl Allergy. 2017 Dec 1;7:43. doi: 10.1186/s13601-017-0180-9. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Purethal Mites, monitoring of allergen specific IgE and monitoring of allergen specific IgG4 in people with Allergen Immunotherapy in Elderly Patients, run by Medical University of Silesia.
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 2 inclusion and 1 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary endpoint was the change from baseline in the mean AAdSS score difference in comparison to placebo. (time frame: baseline and 24 months). 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 NCT03209245, which also lists 1 linked publication.
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 6 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.