A Study to Evaluate the Quality of Life in Male and Female Adult Participants With Severe Asthma Treated With Dupilumab in a Real-world Setting

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

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-03

Study Completion Date

2025-10-10

Brief Summary

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Primary Objective:

\- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.

Secondary Objectives:

* To describe dupilumab HRQoL effectiveness at 12 and 24 weeks compared to baseline.
* To assess the safety during the year of treatment in a real-world setting.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe asthma

Participants with severe asthma starting treatment with dupilumab

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
* Participant for whom decision of initiation and prescription of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was made by the investigator within four weeks before the inclusion in the study. Oral CorticoSteroid (OCS) or non-OCS-dependent patient could be included.
* Participant for whom St. George's Respiratory Questionnaire (SGRQ) score is available within the last 4 weeks prior to dupilumab initiation. SGRQ score could be collected at baseline visit for participants who have not yet started dupilumab.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

* Participant below 18 years of age. - Participant participating in a clinical trial at the time of enrolment.
* Participant under guardianship, trusteeship or under judicial protection.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No