CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,103 enrolled
Drug / intervention
GFF MDI +4 moredrug
Likely dose
Open-label tiotropium bromide inhalation powder (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/NCT01854645
NCT01854645Phase 3Completed
CompareCT.gov

A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

Pearl Therapeutics, Inc.·interventional·Posted May 15, 2013·Updated Mar 28, 2017

In Brief

A Phase 3 clinical trial evaluating GFF MDI, GP MDI, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 2,103 participants across 139 sites in 3 countries.

Detailed Summary

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartMay 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.1 years ago

Interventions

GFF MDIdrug

GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)

GP MDIdrug

GP MDI administered as two puffs BID

FF MDIdrug

FF MDI administered as two puffs BID

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

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

Placebo MDIdrug

Inhaled placebo administered as two puffs BID