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N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03746860
Acronym
CARIOCA
Enrollment
1508
Registered
2018-11-20
Start date
2018-05-09
Completion date
2020-09-29
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma Due to Dermatophagoides Farinae, Allergic Asthma Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite

Keywords

Allergy, Allergic Rhinitis, Allergic Asthma, House Dust Mite, Immunotherapy

Brief 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.

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.

Interventions

DRUGTablet, Dispersible

1 tablet/day with 12 SQ-HDM per lyo-tablet

Sponsors

ITEC Services
CollaboratorOTHER
ALK-Abelló A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Patient who did not have 12 months prior inclusion or have an on-going, House Dust Mite (HDM) Allergy Immunotherapy (AIT).

Design outcomes

Primary

MeasureTime frameDescription
Safety analysis: Number of patients with at least one Adverse Event1 yearNumber of patients with at least one Adverse Events related to ACARIZAX®.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026