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

Phase 3

Completed

• Conditions: COPD
• Interventions: Drug: GFF MDI (PT003); Drug: Symbicort® Turbohaler® Inhalation Powder; Drug: BGF MDI (PT010); Drug: BFF MDI (PT009)

• Registration Number: NCT03262012
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-02-17
• Study Start: 2016-08-09
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-25
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Disposition First Submitted: 2019-03-27
• Disposition First Submitted QC: 2019-04-04
• Disposition First Posted: 2019-04-10
• Results First Submitted: 2020-03-27
• Status Verified: 2020-04
• Results First Submitted QC: 2020-05-01
• Last Update Submitted: 2020-05-01
• Results First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFF MDI (PT003)	GFF MDI (PT003)	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Symbicort® Turbohaler® Inhalation Powder	Symbicort® Turbohaler® Inhalation Powder	Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
BGF MDI (PT010)	BGF MDI (PT010)	Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
BFF MDI (PT009)	BFF MDI (PT009)	Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yokohama-shi, Japan