Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®

Study Overview
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Brief Summary
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A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®

Detailed Description
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This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.

Official Title
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A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control

Conditions
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COPD

Intervention / Treatment
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* Drug: BGF MDI (PT010)
* Drug: GFF MDI (PT003)
* Drug: BFF MDI (PT009)
* Drug: Symbicort® Turbohaler® Inhalation Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Given their signed written informed consent to participate. Subjects must have agreed to participate and complete the lead-in Study PT010006. Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study. Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines. Current or former smokers with a history of at least 10 pack-years of cigarette smoking. Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions). Required COPD maintenance therapy: All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies. Please refer to the study protocol for the complete inclusion criteria list. 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. Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma. Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia. Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated. Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs. Please refer to the study protocol for the complete exclusion criteria list.

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)<br>Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 | Drug: BGF MDI (PT010)<br>* Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010<br>* Other names: BGF;|
| Experimental: GFF MDI (PT003)<br>Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 | Drug: GFF MDI (PT003)<br>* Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003<br>* Other names: GFF;|
| Experimental: BFF MDI (PT009)<br>Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 | Drug: BFF MDI (PT009)<br>* Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009<br>* Other names: BFF;|
| Active Comparator: Symbicort® Turbohaler® Inhalation Powder<br>Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler | Drug: Symbicort® Turbohaler® Inhalation Powder<br>* Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler<br>* Other names: Symbicort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values | Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values | 28 Weeks | 
| Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs | Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs | 28 Weeks | 
| Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values | Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values | 28 Weeks |