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

NCT03262012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2020-05-13

Study results available
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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®

Conditions

Interventions

DRUG

BGF MDI (PT010)

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010

DRUG

GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003

DRUG

BFF MDI (PT009)

Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

DRUG

Symbicort® Turbohaler® Inhalation Powder

Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul M. Dorinsky, MD · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-09
Primary Completion
2018-06-15
Completion
2018-06-15
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262012 on ClinicalTrials.gov