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

Study identifier:PT010005

ClinicalTrials.gov identifier:NCT02465567

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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 over a 52-Week Treatment Period in Subjects with Moderate to Very Severe COPD (ethos)

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

No

Study drug

BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, BFF MDI 320/9.6 μg

Sex

All

Actual Enrollment

8588

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 30 Jun 2015
Primary Completion Date: 26 Jul 2019
Study Completion Date: 26 Jul 2019

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2021 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria