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Completed

NCT Number: NCT03746860

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

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Key information

Conditions

Allergic Rhinitis Due to House Dust Mite Allergic Asthma Due to Dermatophagoides Farinae Allergic Asthma Due to Dermatophagoides Pteronyssinus Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tablet, Dispersible

Drug

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

Other names: ACARIZAX 12 SQ-HDM, Standardised allergen extract from house dust mite

Primary outcomes

  1. 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®.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Collaborators

  • ITEC Services

Registry information

Official study 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

Acronym: CARIOCA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2018
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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