CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,756 enrolled
Drug / intervention
GFF MDI (PT003) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02343458
NCT02343458Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

Pearl Therapeutics, Inc.·interventional·Posted Jan 22, 2015·Updated Feb 20, 2019

In Brief

A Phase 3 clinical trial evaluating GFF MDI (PT003), FF MDI (PT005), and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,756 participants across 166 sites in 11 countries.

Detailed Summary

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesChina, Czechia, Germany, Hungary, Japan, Poland, Russia, South Korea, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 22, 2015
Enrollment StartMar 30, 2015
Primary CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.4 years ago

Interventions

GFF MDI (PT003)drug

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

FF MDI (PT005)drug

Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

GP MDI (PT001)drug

Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Placebo MDIdrug

Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)