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

Asthma Clinical Trial

— DUPIAZA  

Official title:

Real-world Experience of Dupilumab for the Treatment of Severe Asthma in the United Kingdom: a Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06064526
• Other study ID #: CEF0101
• Secondary ID: U1111-1294-7718C
• Status: Active, not recruiting
• Start date: April 19, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• No intervention
Non-interventional study based on secondary use of hospital medical records

Locations

Country	Name	City	State
France	Sanofi-Aventis, France	Chilly-Mazarin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral corticosteroid (OCS) dose	Measured per day	Up to 25 months
Primary	Annual asthma exacerbation rate	The annual exacerbation rate will be calculated as the sum of OCS exacerbations and the hospital asthma exacerbations that occurred more than 7 days separated from other exacerbations. Exacerbations will be defined according to whether or not the patient was receiving asthma maintenance OCS.	Up to 25 months
Primary	Forced expiratory volume in one second (FEV1)	FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer measured in L	Up to 25 months
Primary	Peak expiratory flow rate (PEF)	The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter measured in L/min.	Up to 25 months
Primary	Asthma Control Questionnaire (ACQ) score	Total scores for the different versions of ACQ (5/6/7) are highly correlated and measurement properties are reported to be similar but results will be reported separately according to the version used. Differences in ACQ will only be calculated where the same version was used for the time points being compared. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.	Up to 25 months
Primary	Asthma Quality of Life Questionnaire (AQLQ) score	Overall scores for the mini-AQLQ and the AQLQ have been reported to be very similar but results will be reported separately according to the version used. Differences in AQLQ will only be calculated where the same version was used for the time points being compared. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.	Up to 25 months
Secondary	Body mass index (BMI [kg/m2])	Calculated as weight at baseline (kg) divided by height in m2	At baseline
Secondary	Inhaled corticosteroid dose	Measured per day	At baseline
Secondary	Dupilumab treatment duration	Time from the first dose to the last recorded dose (information on treatment interruptions will not be collected).	Up to 25 months