Dupilumab for Severe Asthma in a Real Life Setting

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04022447
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    retrospective data collection

Study Details

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.

Key Dates

Start date
Aug 10, 2018
Status verified
Jul 2019
Primary completion
Apr 2, 2019
Completion
Apr 2, 2019

Study Design

Enrollment
86 participants (actual)

Primary Outcome Measure

asthma control with dupilumab [ Time Frame: 12 months ]

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