Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study identifier:PT010008

ClinicalTrials.gov identifier:NCT02536508

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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, BFF MDI 320/9.6 μg

Sex

All

Actual Enrollment

627

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 10 Aug 2015
Primary Completion Date: 12 Sept 2017
Study Completion Date: 12 Sept 2017

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