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OpenTrials
Completed

NCT Number: NCT06064526

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis, France

Chilly-Mazarin, 91380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Oral corticosteroid (OCS) dose

    Time frame: Up to 25 months

    Measured per day

  2. Annual asthma exacerbation rate

    Time frame: 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.

  3. Forced expiratory volume in one second (FEV1)

    Time frame: 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

  4. Peak expiratory flow rate (PEF)

    Time frame: 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.

  5. Asthma Control Questionnaire (ACQ) score

    Time frame: 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.

  6. Asthma Quality of Life Questionnaire (AQLQ) score

    Time frame: 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.

Secondary outcomes

  1. Body mass index (BMI [kg/m2])

    Time frame: At baseline

    Calculated as weight at baseline (kg) divided by height in m2

  2. Inhaled corticosteroid dose

    Time frame: At baseline

    Measured per day

  3. Dupilumab treatment duration

    Time frame: Up to 25 months

    Time from the first dose to the last recorded dose (information on treatment interruptions will not be collected).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: DUPIAZA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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