Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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COPD

Intervention / Treatment
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* Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Give their signed written informed consent to participate. Are at least 40 years of age and no older than 80 at Visit 1. A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS). Current or former smokers with a history of at least 10 pack-years of cigarette smoking. FEV1/FVC ratio of <0.70. Post-bronchodilator FEV1 must be ≥ 30% and <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL. Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol. Exclusion Criteria: Pregnancy, nursing females or subjects trying to conceive. Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study. Current primary diagnosis of asthma. History of ECG abnormalities. Poorly controlled or worsening COPD prior to Screening or during the Screening Period. Clinically significant bladder neck obstruction or urinary retention. Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening. Cancer that has not been in complete remission for at least five years. Inadequately treated glaucoma. History of allergic reaction or hypersensitivity to any component of the formulations used in this study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler<br>Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003 | Drug: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler<br>* GFF MDI administered as 2 inhalations BID<br>* Other names: GFF MDI, PT003;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Over the life of the canister/120 puffs - up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount) | 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 | Over the life of the canister/120 puffs - up to 4 weeks |