Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting

21-0273

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.

2022-03-01

2023-02-13

2023-02-13

Completed

54

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive the intervention consisting of Albuterol eMDPI DS (ProAir® Digihaler®). Participants will be asked to use the ProAir Digihaler as their primary mode of SABA therapy as they would in usual treatment and indicated in the product package insert and Instructions for Use. They will answer a daily self-assessment on the DAQ App, as well as Digihaler metric algorithm-triggered DAQ on the DAQ app. The DAQ will collect yes/no responses to questions focused on change in symptoms. The participants will be contacted once per month to collect COPD Assessment Test (CAT) score and self-reported average albuterol use over the preceding month. They will also be asked about any AECOPD events requiring treatment.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study.'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2024-01-23