Dupilumab for Severe Asthma in a Real Life Setting

NCT04022447 | Completed

• 1 other identifier: HAO 18053
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Asthma

Keywords

dupilumab; asthma; real life; safety

Outcome Measures

Primary Outcomes (5)

• asthma control with dupilumab

  asthma control evaluated by Asthma Control Test

  12 months

• number of asthma exacerbations

  number of self reported asthma exacerbations, defined by the use of oral steroids for at least 3 days

  12 months

• number of asthma-related hospitalizations

  number of self reported or documented in the medical file asthma-related hospitalizations

  12 months

• FEV1 (Forced Expiratory Volume in 1 sec)

  FEV1 (Forced Expiratory Volume in 1 sec) expressed in ml

  12 months

• oral steroids consumption

  daily dose of prednisone (mg)

  12 months

Interventions

Dupilumab DRUG

retrospective data collection

Also known as: retrospective non interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between September 2017 and January 2018, 86 TUA applications were registered from 13 different teaching hospitals nationwide. 17 patients did not eventually receive the treatment and 69 were thus screened for study.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat-Claude Bernard University Hospital

Paris, 75018, France

Location

Related Publications (1)

• Dupin C, Belhadi D, Guilleminault L, Gamez AS, Berger P, De Blay F, Bonniaud P, Leroyer C, Mahay G, Girodet PO, Raherison C, Fry S, Le Bourdelles G, Proust A, Rosencher L, Garcia G, Bourdin A, Chenivesse C, Didier A, Couffignal C, Taille C. Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. Clin Exp Allergy. 2020 Jul;50(7):789-798. doi: 10.1111/cea.13614. Epub 2020 May 29.

  PMID: 32469092 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Camille TAILLE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: August 10, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-07

Locations

FR (1)