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 (PROVERB)

Sanofi

Status: Active, not recruiting

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT06018441

U1111-1279-3274 (Registry Identifier)

OBS17526

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

112 participants in 1 patient group

Severe asthma

Description:

Participants with severe asthma starting treatment with dupilumab