Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Detailed Description
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A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Official Title
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A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Conditions
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COPD

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001) Exclusion Criteria: Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery

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 MDI (PT010) 320/14.4/9.6 μg<br>Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI) | Drug: BGF MDI 320/14.4/9.6 μg<br>* Budesonide, Glycopyrronium, and Formoterol Fumarate<br>* Other names: BGF MDI;|
| Experimental: GFF MDI (PT003) 14.4/9.6 μg<br>Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI) | Drug: GFF MDI 14.4/9.6 μg<br>* Glycopyrronium and Formoterol Fumarate<br>* Other names: GFF MDI;|
| Experimental: BFF MDI (PT009) 320/9.6 μg<br>Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI) | Drug: BFF MDI 320/9.6 μg<br>* Budesonide and Formoterol Fumarate<br>* Other names: BFF MDI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in BMD of the Lumbar Spine | Percent change from baseline in BMD of the lumbar spine T-Score at Week 52. | at week 52 | 
| Change From Baseline in the LOCS III (P) Score at Week 52 | Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin. | at week 52 |