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®
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
416
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
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
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs
Time frame: 28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values
Time frame: 28 Weeks
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Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Research Site
Bunkyō City, Japan
Research Site
Chūōku, Japan
Research Site
Chūōku, Japan
Research Site
Chūōku, Japan
Research Site
Date-gun, Japan
Research Site
Fukuoka, Japan
Research Site
Ginowan-shi, Japan
Research Site
Hakata-shi, Japan
Research Site
Hamamatsu, Japan
Research Site
Hamamatsu, Japan
...and 69 more locations