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

NCT ID: NCT03746860

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-09

Study Completion Date

2020-09-29

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tablet, Dispersible

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

Intervention Type DRUG

Other Intervention Names

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ACARIZAX 12 SQ-HDM Standardised allergen extract from house dust mite

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ITEC Services

OTHER

Sponsor Role collaborator

ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal DEMOLY, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Arnaud de Villeneuve - 34090 Montpellier - FRANCE

Locations

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Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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ID-RCB:2017-A02668-45

Identifier Type: OTHER

Identifier Source: secondary_id

NI-MT-05

Identifier Type: -

Identifier Source: org_study_id

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