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A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)

NCT02497001 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1902

Last updated 2020-12-24

Study results available
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Summary

Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.

Conditions

Interventions

DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])

DRUG

GFF MDI (PT003) 14.4/9.6 μg

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)

DRUG

BFF MDI (PT009) 320/9.6 μg

Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)

DRUG

Symbicort® Turbuhaler® (TBH) Inhalation Powder

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Dorinsky, MD · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-10
Primary Completion
2018-01-05
Completion
2018-01-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • 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 NCT02497001 on ClinicalTrials.gov