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

NCT06064526 | Completed

• 2 other identifiers: CEF0101U1111-1294-7718
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (6)

• Oral corticosteroid (OCS) dose

  Measured per day

  Up to 25 months

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Body mass index (BMI [kg/m2])

  At baseline

• Inhaled corticosteroid dose

  At baseline

• Dupilumab treatment duration

  Up to 25 months

Study Arms (1)

Group 1

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

Other: No intervention

Interventions

No intervention OTHER

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants with severe asthma treated with dupilumab in routine clinical practice from medical records of nine participating centres meeting the study eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis, France

Chilly-Mazarin, 91380, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: April 19, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)