An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma (DUPIAZA)

Sanofi

Status: Completed

Conditions: Asthma

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06064526

U1111-1294-7718 (Registry Identifier)

CEF0101

Details and patient eligibility

About

The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.

Full description

Participants initiating treatment with dupilumab in the UK between 5th July 2019 and 12th August 2021 will be included in the study record review, permitting participation in research and if medical records are available for review. No intervention will be administered in this clinical trial. Data will be collected from hospital medical records and other hospital databases.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants (aged ≥18 years at index) with severe asthma, initiated with dupilumab treatment (≥1 dose) between 07/05/2019 (EU licence) and 08/12/2021 • Participants with ≥1 routine asthma clinic visit recorded within 6 months prior to or on the date of dupilumab initiation and ≥1 routine asthma clinic visit recorded between 9 and 16 months post-dupilumab initiation

Exclusion criteria

• Participants known to have opted out of participation in research • Participants whose medical records are not available for review The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

144 participants in 1 patient group

Group 1

Description:

The source population for this study is adult participants with severe asthma treated with dupilumab in routine clinical practice in the UK.

Treatment:

Other: No intervention