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

May 14, 2021 updated by: ALK-Abelló A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Hôpital Arnaud de Villeneuve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

ITEC Services

Investigators

  • Principal Investigator: Pascal DEMOLY, Pr, Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Actual)

September 29, 2020

Study Completion (Actual)

September 29, 2020

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-MT-05
  • ID-RCB:2017-A02668-45 (Other Identifier: Comité de Protection des Personnes SUD MEDITERRANNEE IV)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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