Perennial Allergic RhinitisNCT03127436
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe
An observational study of Perennial Allergic Rhinitis, run by University Hospital of Cologne at 1 site in Austria.
Trial summary
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Acarovac
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2017to 14 Feb 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults, adolescents and children from the age of 5 on, who suffer from perenial allergic rhinoconjunctivitis causued by house dust mites.
Who may be able to join
- Patients of the age of 5 years and older suffering from a house dust mite induced allergic rhinitis
Who cannot join
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
- Patients suffering from severe and uncontrolled asthma
- Patients with a known severe autoimmune disease
- Patients with active malignant disease
- Patients requiring beta-blockers
- Patients having any contraindication for the use of adrenaline
- Patients with a hypersensitivity to the excipients of the drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe
Read the detailed description
This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.
During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
Data on tolerability are documented by the physicians.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Acarovac
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarovacDrug
House dust mite sensitized Patients receive increasing doses of subcutaneous immunotherapy with Acarovac. During the up-dosing phase, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
| Study group | Role | What they receive |
|---|---|---|
| Acarovac Hausstaubmilbe | This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac in house dust mite allergic patients (children and adults) in routine medical care.
During the up-dosing phase with Acarovac, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
Data on tolerability are documented by the physicians. Receives: Drug: Acarovac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of treatment-related local and systemic reactions following SCIT administration
Tolerability and safety will be assessed by the frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm ) and systemic reactions (skin, airways, others) through study completion.
The study covers the four injections of the up-dosing phase and one injection of the maintenance phase of the immunotherapy course.
Measured: over the overall duration of the study
Secondary outcomes (4)
Safety and Tolerability - frequency and intensity of adverse events
Frequency and intensity of adverse events
Measured: over the overall duration of the study
Safety and Tolerability - local reactions at injection site
Frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm )
Measured: over the overall duration of the study
Safety and Tolerability - Number of systemic reactions
Frequency and intensity of systemic reactions
Measured: over the overall duration of the study
Changes in rhinoconjunctivitis score
The rhinoconjunctivitis score combines rhinitis symptom intensity and conjunctivitis symptom intensity and will be assessed retrospectively and after the course of treatment
Measured: baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Mar 2017
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Bencard Allergie GmbH
- Responsible party
- Principal investigator, Prof. Dr. Ralph Mösges, University Hospital of Cologne
- Investigators
- Matthias Kramer, Prof. Dr., Study director, Bencard Allergie GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127436
- Sponsor's protocol ID
- Acarovac AT
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma
- ClinicalTrials.gov ID
- NCT03127436
- Acronym / sponsor ID
- Acarovac AT
- Conditions
- Perennial Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Bencard Allergie GmbH
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 25 Apr 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.
Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe
Detailed description
This prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac® in house dust mite allergic patients in routine medical care.
During the up-dosing phase with Acarovac®, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
Data on tolerability are documented by the physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acarovac Hausstaubmilbe | – | Drug: AcarovacThis prospective open multi-centre non-interventional study was initiated to document the tolerability and the safety profile of the subcutaneous allergen-specific immunotherapy with Acarovac in house dust mite allergic patients (children and adults) in routine medical care. During the up-dosing phase with Acarovac, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval. Data on tolerability are documented by the physicians. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, adolescents and children from the age of 5 on, who suffer from perenial allergic rhinoconjunctivitis causued by house dust mites.
Key inclusion criteria (1 listed)
- Patients of the age of 5 years and older suffering from a house dust mite induced allergic rhinitis
Key exclusion criteria (8 listed)
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
- Patients suffering from severe and uncontrolled asthma
- Patients with a known severe autoimmune disease
- Patients with active malignant 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 |
|---|---|---|
| AcarovacHouse dust mite sensitized Patients receive increasing doses of subcutaneous immunotherapy with Acarovac. During the up-dosing phase, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval. | Drug | Acarovac Hausstaubmilbe |
Primary outcome
Numbers of treatment-related local and systemic reactions following SCIT administration
Time frame: over the overall duration of the study
Tolerability and safety will be assessed by the frequency and intensity of local reactions at the injection site (wheal size 5-10 cm, > 10 cm ) and systemic reactions (skin, airways, others) through study completion. The study covers the four injections of the up-dosing phase and one injection of the maintenance phase of the immunotherapy course.
4 secondary outcomes
Safety and Tolerability - frequency and intensity of adverse events
Time frame: over the overall duration of the study
Safety and Tolerability - local reactions at injection site
Time frame: over the overall duration of the study
Safety and Tolerability - Number of systemic reactions
Time frame: over the overall duration of the study
Changes in rhinoconjunctivitis score
Time frame: baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme
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 24 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Matthias Kramer, Prof. Dr. study director
Bencard Allergie GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perennial Allergic Rhinitis, run by University Hospital of Cologne at 1 site in Austria.
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 8 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 24 Apr 2019. 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 Austria. 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.
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?
Numbers of treatment-related local and systemic reactions following SCIT administration (time frame: over the overall duration of the study). 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 24 Apr 2019.