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Pivotal study to assess the efficacy, safety and tolerability of dupilumab in patients with moderate-to- severe COPD with Type 2 inflammation (BOREAS)

University of North Carolina at Chapel Hill


Description

The goal of this study is to evaluate an investigational medication and its effect on lung function and symptom control. Participants will either be given either the active medication or a placebo (inactive solution that does not contain medication) as an injection given every two weeks in clinic for one year.


Keywords:

Breathing, Lungs, Smoking


Category:

Drug or Biologic
Phase:2

Qualifications

 


Age
40 - 80 years


Gender
Any


Study Population

Patients who have been diagnosed with moderate to severe COPD and have been on inhalers. Eligible participants should be between the ages of 40 to 80, and on daily inhalers, and have had at least one breathing flare in the past year.


Investigator

Brad Drummond
Associate Professor
Medicine-Pulmonary

For questions, contact:

Andrea McDaniel-Harper
harper41@email.unc.edu
(984) 974-2969
Visit Website

Recruitment Period End

June 18, 2021

Location

Primary Location
300 meadowmont Village Circle Chapel Hill, NC 27517, USA
300 Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Study Qualifications

Gender Any

Age Range 40 - 80 years

Participant qualification(s) Age 40 to 80 Diagnosed with COPD, emphysema, or chronic bronchitis on daily inhalers History of two or more flares of COPD

Not eligible if: Females who are currently pregnant or breastfeeding Oxygen use for more than 12 hours a day Evidence of Right Cardiac failure

Number of Visits

    » 31 In person visit(s)

    1 screening 1 randomization 28 clinic

    » 0 Remote visit(s)

Participation Period

76 weeks

Compensation

up to $2,260

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.