24-hour Lung Function in Subjects with Moderate to Very Severe COPD after Treatment with PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo

Study identifier:PT003011-00

ClinicalTrials.gov identifier:NCT02347072

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

No

Study drug

GFF MDI (PT003), Placebo MDI, Spiriva® Respimat® (Tiotropium Bromide)

Sex

All

Actual Enrollment

80

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Feb 2015
Primary Completion Date: 01 Aug 2015
Study Completion Date: 01 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: Efficacy
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