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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-19

Study Completion Date

2024-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

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

No intervention

Intervention Type OTHER

Non-interventional study based on secondary use of hospital medical records

Interventions

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No intervention

Non-interventional study based on secondary use of hospital medical records

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No