This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
GFF MDI administered as 2 inhalations BID
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count
Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit
Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit
Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.
Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)
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Charlotte, North Carolina, United States
Pearl Investigative Site
Columbus, Ohio, United States
Pearl Investigative Site
Medford, Oregon, United States
Pearl Investigative Site
Greenville, South Carolina, United States
Pearl Investigative Site
Rock Hill, South Carolina, United States
Pearl Investigative Site
Spartanburg, South Carolina, United States
Pearl Investigative Site
Richmond, Virginia, United States
Percentage of devices where the dose indicator actuation count is \>20 less than the subject-reported actuation count (undercount)
Time frame: Over the life of the canister/120 puffs - up to 4 weeks
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count
Time frame: Over the life of the canister/120 puffs - up to 4 weeks