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A study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD (chronic obstructive pulmonary disease) patients with Type 2 inflammation.

Short Title: Vigilant


Enrollment Status: Recruiting

NCT #: NCT07177339

Specialty Area: Pulmonology

Condition Studied: Chronic Obstructive Pulmonary Disease

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 40-75 years of age
  • Clinically documented history of COPD for at least 1 year
  • Have had one COPD exacerbation in the last 12 months
  • Current or former smoker with history of > 10 pack-years
  • Optimized dual or triple inhaler therapy
  • A post-salbutamol forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values

What's Involved

Participation in the study will include:
  • Administration of the study medication
  • Spirometry test to measure airflow and lung capacity
  • Collection of a mucus sample from the lower airways (induced sputum)
  • Maintaining an E-diary
  • Completing health outcome assessments
  • Electrocardiogram (ECG)
  • Lab draw
  • High resolution computed tomography
  • Magnetic resonance imaging (MRI)

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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