Status:
COMPLETED
Digihaler in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Wake Forest University Health Sciences
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics \[peak inspiratory flow (PIF), inhalation volume, number of inhalation events\] amongst COPD patients in the...
Detailed Description
The albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) (ProAir® Digihaler®) is the first and only Food and Drug Administration (FDA) approved inhaler rescu...
Eligibility Criteria
Inclusion
- Age \>40 years old
- History of cigarette smoking \>=10 pack-years
- Established COPD defined as physician diagnosis along with spirometry confirmation \[post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC)\<0.70\] within the last two years and an FEV1 ≤80% predicted
- Regular albuterol use (defined as at least one puff weekly for each of the last four weeks)
- Currently non-hospitalized
- Medical records confirmed history of two moderate AECOPD (defined as use of antibiotic or steroids to treat clinical event consistent with AECOPD) or one severe AECOPD (defined as emergency department/hospital visit) in prior 12 months
- Access to smart phone, tablet or computer and internet
- Willingness to switch current rescue inhaler/device to ProAir Digihaler
Exclusion
- Allergy or inability/contraindication to use Albuterol Sulfate
- Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05241288
Start Date
March 1 2022
End Date
February 13 2023
Last Update
January 23 2024
Active Locations (2)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
2
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157