An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma
- Conditions
- Asthma
- Interventions
- Other: No intervention
- Registration Number
- NCT06064526
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
• 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
• 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 No intervention The source population for this study is adult participants with severe asthma treated with dupilumab in routine clinical practice in the UK.
- Primary Outcome Measures
Name Time Method Oral corticosteroid (OCS) dose Up to 25 months Measured per day
Annual asthma exacerbation rate Up to 25 months 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.
Forced expiratory volume in one second (FEV1) Up to 25 months FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer measured in L
Peak expiratory flow rate (PEF) Up to 25 months The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter measured in L/min.
Asthma Quality of Life Questionnaire (AQLQ) score Up to 25 months 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.
Asthma Control Questionnaire (ACQ) score Up to 25 months 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.
- Secondary Outcome Measures
Name Time Method Body mass index (BMI [kg/m2]) At baseline Calculated as weight at baseline (kg) divided by height in m2
Dupilumab treatment duration Up to 25 months Time from the first dose to the last recorded dose (information on treatment interruptions will not be collected).
Inhaled corticosteroid dose At baseline Measured per day
Trial Locations
- Locations (1)
Sanofi-Aventis, France
🇫🇷Chilly-Mazarin, France