Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT03746860
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2018-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
Sponsor:
ALK-Abelló A/S
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARIOCA
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID-RCB:2017-A02668-45 | OTHER | Comité de Protection des Personnes SUD MEDITERRANNEE IV | View |