A study to assess the effects of PT003 and Placebo MDI on specific image based airway volumes and resistance in subjects with moderate to severe COPD

Study identifier:PT003018

ClinicalTrials.gov identifier:NCT02643082

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

No

Study drug

GFF MDI (PT003) 14.4/9.6μg, Placebo MDI

Sex

All

Actual Enrollment

20

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 23 Dec 2015
Primary Completion Date: 26 Jan 2017
Study Completion Date: 26 Jan 2017

Study design

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

Verification:

Verified 01 Apr 2019 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria