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Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

NCT02465567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8588

Last updated 2021-02-02

Study results available
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Summary

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Conditions

Interventions

DRUG

BGF MDI 320/14.4/9.6 μg

Budensonide, Glycopyrronium, and Formoterol Fumarate

DRUG

GFF MDI 14.4/9.6 μg

Glycopyrronium, and Formoterol Fumarate

DRUG

BGF MDI 160/14.4/9.6 μg

Budensonide, Glycopyrronium, and Formoterol Fumarate

DRUG

BFF MDI 320/9.6 μg

Budensonide, and Formoterol Fumarate

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul M Dorinsky, MD · Pearl Therapeutics

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
2015-06-30
Primary Completion
2019-07-26
Completion
2019-07-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

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 NCT02465567 on ClinicalTrials.gov