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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-3274 | Registry Identifier | ICTRP |
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Primary Objective:
- To describe dupilumab health-related quality of life (HRQoL) effectiveness at 52 weeks compared to baseline.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe asthma | Participants with severe asthma starting treatment with dupilumab |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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Participants with severe asthma
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | France | France |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline (Day 0), Week 12 and Week 24 |
| Number of participants with adverse events (AEs) | Day 0 to Week 52 |
| Number of participants with serious adverse events (SAEs) | Day 0 to Week 52 |
| Number of participants with adverse events of special interest | Day 0 to Week 52 |
| Number of participants with medication errors | Day 0 to Week 52 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |