Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

Completed · Not applicable

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT05241288

Run by

University of North Carolina, Chapel Hill

People needed

54

Starts

2022-03-01

Expected to finish

2023-02-13

Last updated by the study team

2024-01-23

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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