Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 ambulatory setting.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Wake Forest University Health Sciences
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• 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 Criteria:

• Allergy or inability/contraindication to use Albuterol Sulfate

• Frequent use of nebulizer (i.e., >1 time per day)

• Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study