CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,615 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/NCT01854658
NCT01854658Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind (Test Products and Placebo), 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 May 15, 2013·Updated Mar 28, 2017

In Brief

A Phase 3 clinical trial evaluating GFF MDI (PT003), GP MDI (PT001), and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,615 participants across 113 sites.

Detailed Summary

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJul 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.1 years ago

Interventions

GFF MDI (PT003)drug

GFF MDI administered as two puffs BID

GP MDI (PT001)drug

GP MDI administered as two puffs BID

FF MDI (PT005)drug

FF MDI administered as two puffs BID

Placebodrug