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Not yet recruiting NCT07612878

The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry

— Observational COPD (Chronic Obstructive Pulmonary Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cohort 1: Dupilumab, Cohort 2: usual care only.
Who it may be relevant to
Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.

Detailed description

This registry will enroll 350 participants with COPD newly initiated in dupilumab over a period of approximately 12 months at approximately 20 US sites experienced in the diagnosis and treatment of COPD. Data, chest images, and home spirometries will be collected from participants for approximately 2 years. Participant management and treatment decisions will be determined by participants and their health care professionals.

Interventions

  • Drug Cohort 1: Dupilumab
    medicine already approved by the FDA
  • Other Cohort 2: usual care only
    Usual care that patients receive

Primary outcome measures

  • Participant Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Participant Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Participant Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patients Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patients Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Time frame: End of study (24 months after the last participant is enrolled)]
Secondary outcome measures (9)
  • COPD Exacerbations [Time frame: End of Study (24 months after the last participant is enrolled)]
  • FEV changes [Time frame: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Time frame: End of study (2 years after the last participant is enrolled)]
  • Events [Time frame: End of study (2 years after the last participant is enrolled)]
  • COPD Exacerbations [Time frame: End of study (24 months after the last participant is enrolled)]
  • COPD Exacerbations [Time frame: End of study (24 months after the last participant is enrolled)]
  • Changes in Quality of Life [Time frame: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Time frame: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Time frame: End of study (2 years after the last participant is enrolled)]

Eligibility criteria

Inclusion criteria

  • COPD patients who are newly referred to start dupilumab treatment
  • Age ≥ 40 years
  • Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit

Exclusion criteria

  • Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)
  • Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments
  • Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07612878 · Pro00119059 · SANOFI STUDY No: OBS21707

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗