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

Allergic Rhinitis Due to House Dust Mite Clinical Trial

— CARIOCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746860
• Other study ID #: NI-MT-05
• Secondary ID: ID-RCB:2017-A026
• Status: Completed
• Start date: May 9, 2018
• Est. completion date: September 29, 2020

Study information

• Verified date: May 2021
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1508
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tablet, Dispersible
1 tablet/day with 12 SQ-HDM per lyo-tablet

Locations

Country	Name	City	State
France	Hôpital Arnaud de Villeneuve	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	ITEC Services

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety analysis: Number of patients with at least one Adverse Event	Number of patients with at least one Adverse Events related to ACARIZAX®.	1 year