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

Asthma Clinical Trial

— PROVERB  

Official title:

National, Multicenter, Non-interventional, Prospective Study to Explore the Quality of Life of Patients With Severe Asthma Starting Treatment With Dupilumab (Dupixent®) in a Real-world Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018441
• Other study ID #: OBS17526
• Secondary ID: U1111-1279-3274
• Status: Recruiting
• Start date: October 3, 2023
• Est. completion date: October 3, 2025

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 3, 2025
• Est. primary completion date: October 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Investigational Site	France

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline (Day 0), Week 52
Secondary	Change from baseline in health-related quality of life (HRQoL), as measured by the St. George's Respiratory Questionnaire (SGRQ)	The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.	Baseline (Day 0), Week 12 and Week 24
Secondary	Number of participants with adverse events (AEs)		Day 0 to Week 52
Secondary	Number of participants with serious adverse events (SAEs)		Day 0 to Week 52
Secondary	Number of participants with adverse events of special interest		Day 0 to Week 52
Secondary	Number of participants with medication errors		Day 0 to Week 52