CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 892 enrolled
Drug / intervention
GFF MDI (PT 003) +3 moredrug
Likely dose
Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) 18 μgfrom 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/NCT01970878
NCT01970878Phase 3Completed
CompareCT.gov

A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

Pearl Therapeutics, Inc.·interventional·Posted Oct 28, 2013·Updated Mar 17, 2017

In Brief

A Phase 3 clinical trial evaluating GFF MDI (PT 003), GP MDI (PT001), and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 892 participants across 125 sites in 3 countries.

Detailed Summary

This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesAustralia, New Zealand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 28, 2013
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

GFF MDI (PT 003)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

Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)drug

Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)