Severe Asthma Clinical Trial
— DUPI-FranceOfficial title:
Dupilumab Effectiveness in Severe Asthma: a Cohort Study From a Nationwide Early Access
NCT number | NCT04022447 |
Other study ID # | HAO 18053 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 10, 2018 |
Est. completion date | April 2, 2019 |
Verified date | July 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Dupilumab is a monoclonal anti-IL-4/13Rα antibody developed for severe asthma (SA). In France, mepolizumab was commercialized in February 2018. Before this date, many SA patients had reached a therapeutic dead end, with uncontrolled disease despite maximal available treatment. Upon the request of lung specialists involved in SA, French health authorities approved an early access program (temporary Use Authorization) allowing early access to dupilumab (before EMA's decision) from September 2017 to January 2018, for SA patients demonstrating unacceptable steroids side effects and/or life-threatening exacerbations, irrespective of their T2 status.The aim of this retrospective study was to describe the characteristics of SA patients included in the early access program and to assess changes in asthma control after a 12 months treatment.
Status | Completed |
Enrollment | 86 |
Est. completion date | April 2, 2019 |
Est. primary completion date | April 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - French patient with Severe Asthma - Administration of dupilumab under the TUA between September 2017 and January 2018, with at least one injection - Realization of at least one follow-up visit in the first 12 months of treatment Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
France | Bichat-Claude Bernard University Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | asthma control with dupilumab | asthma control evaluated by Asthma Control Test | 12 months | |
Primary | number of asthma exacerbations | number of self reported asthma exacerbations, defined by the use of oral steroids for at least 3 days | 12 months | |
Primary | number of asthma-related hospitalizations | number of self reported or documented in the medical file asthma-related hospitalizations | 12 months | |
Primary | FEV1 (Forced Expiratory Volume in 1 sec) | FEV1 (Forced Expiratory Volume in 1 sec) expressed in ml | 12 months | |
Primary | oral steroids consumption | daily dose of prednisone (mg) | 12 months |
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