Study to Assess the Efficacy and Safety of PT003 in Subjects with Moderate to Severe COPD

Study identifier:PT003013

ClinicalTrials.gov identifier:NCT02454959

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects with Moderate to Very Severe COPD with and without a Valved Holding Chamber

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

No

Study drug

GFF MDI (PT003) without Aerochamber

Sex

All

Actual Enrollment

80

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 May 2015
Primary Completion Date: 25 Mar 2016
Study Completion Date: 25 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria