To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

Detailed Description
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This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

Official Title
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A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: BGF 320/14.4/9.6 µg MDI
* Drug: BFF 320/9.6 µg


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Signed Informed Consent Subjects with an established clinical history of COPD Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening Current or former smokers with a history of at least 10 pack-years of cigarette smoking Women of Non-childbearing potential Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently Key Exclusion Criteria: Significant diseases or conditions other than COPD, which in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception Current diagnosis of asthma Uncontrolled sleep apnea Other Serious Respiratory Disorders Hospitalized due to poorly controlled COPD within 6 weeks Poorly Controlled COPD Immune deficiency and/or severe neurological disorders affecting control of the upper airway Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGF 320/14.4/9.6 µg MDI BID<br>Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI) | Drug: BGF 320/14.4/9.6 µg MDI<br>* Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)<br>* Other names: PT010;|
| Experimental: BFF 320/9.6 µg MDI BID<br>Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI) | Drug: BFF 320/9.6 µg<br>* Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)<br>* Other names: PT009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in morning pre-dose trough FEV1 |  | Week 12 | 
| Peak change from baseline in inspiratory capacity |  | Week 12 | 
| Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ) |  | Week 12 | 
| Time to first clinically important deterioration (CID) in COPD |  | 12 weeks | 
| Change from baseline in average daily rescue Ventolin HFA use |  | 12 weeks | 
| Peak change from baseline in FEV1 |  | Week 12 | 
| Time to onset of action |  | Day 1 |