NCT02347072

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	GFF MDI (PT003)
DRUG	Placebo MDI
DRUG	Spiriva® Respimat® (Tiotropium Bromide)	Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2016-03-01
• First posted: 2015-01-27
• Last updated: 2017-04-19
• Results posted: 2017-04-19