Allergic Rhinitis Due to House Dust MiteCARIOCANCT03746860
N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
An observational study of Allergic Rhinitis Due to House Dust Mite and Allergic Asthma Due to Dermatophagoides Farinae, run by ALK-Abelló A/S at 1 site in France.
Trial summary
Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis Due to House Dust Mite, Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus
- What is being tested?
- Tablet, Dispersible
- Type of treatment
- Pill or oral medicine
- How many people
- 1,508 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2018to 29 Sep 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients are only included in the study after the decision for treatment with ACARIZAX® has already been made, and only with the objective of documenting data that reflects the treatment and its safety under 'real life' conditions. Accordingly, only examinations and inquiries conforming to routine practice are conducted and documented.
Who may be able to join
- At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent
Who cannot join
- Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France
Non-interventional study to investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.
Read the detailed description
Condition:
- persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.
- Conditions
- Allergic Rhinitis Due to House Dust Mite, Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus
- Being tested
- Tablet, Dispersible
- Keywords
- Allergy, Allergic Rhinitis, Allergic Asthma, House Dust Mite, Immunotherapy
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet, DispersibleDrug
Also called ACARIZAX 12 SQ-HDM, Standardised allergen extract from house dust mite
1 tablet/day with 12 SQ-HDM per lyo-tablet
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety analysis: Number of patients with at least one Adverse Event
Number of patients with at least one Adverse Events related to ACARIZAX®.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start9 May 2018
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis Due to House Dust MiteStudies 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
- 1,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, Pr, Principal investigator, Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746860
- Sponsor's protocol ID
- NI-MT-05
- Other IDs
- ID-RCB:2017-A02668-45
- Acronym
- CARIOCA
- Status last verified
- May 2021
- First submitted
- 12 Nov 2018
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Safety and Use of Allergy Immunotherapy ACARIZAX® 12 SQ-HDM in Real-life Clinical Practice in Adult Patients With House Dust Mite Allergy in France
- ClinicalTrials.gov ID
- NCT03746860
- Acronym / sponsor ID
- CARIOCA / NI-MT-05
- Conditions
- Allergic Rhinitis Due to House Dust Mite, Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus
- Keywords
- Allergy, Allergic Rhinitis, Allergic Asthma, House Dust Mite, Immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,508 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Study start
- 9 May 2018 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 20 Nov 2018 (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 investigate the safety and tolerability of allergy immunotherapy ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house dust mite allergy over a period of 12 months.
Detailed description
Condition:
- persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients are only included in the study after the decision for treatment with ACARIZAX® has already been made, and only with the objective of documenting data that reflects the treatment and its safety under 'real life' conditions. Accordingly, only examinations and inquiries conforming to routine practice are conducted and documented.
Key inclusion criteria (1 listed)
- At the discretion of the investigator, patient who will be prescribed ACARIZAX® in line with the approved Summary of Product Characteristics (SmPC) and who have been informed, after explicit written explanation and willing to participate in the study by signed consent
Key exclusion criteria (1 listed)
- Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).
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 |
|---|---|---|
| Tablet, DispersibleAlso: ACARIZAX 12 SQ-HDM, Standardised allergen extract from house dust mite1 tablet/day with 12 SQ-HDM per lyo-tablet | Drug | – |
Primary outcome
Safety analysis: Number of patients with at least one Adverse Event
Time frame: 1 year
Number of patients with at least one Adverse Events related to ACARIZAX®.
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 17 May 2021.
- 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.
Pascal DEMOLY, Pr principal investigator
Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE
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 Allergic Rhinitis Due to House Dust Mite and Allergic Asthma Due to Dermatophagoides Farinae, run by ALK-Abelló A/S at 1 site in France.
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 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 17 May 2021. 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 France. 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?
Safety analysis: Number of patients with at least one Adverse Event (time frame: 1 year). 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 17 May 2021.