CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
GFF MDI (PT003) with Aerochamber +1 moredevice
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/NCT02454959
NCT02454959Phase 3Completed
CompareCT.gov

A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects With Moderate to Very Severe COPD With and Without a Valved Holding Chamber

Pearl Therapeutics, Inc.·interventional·Posted May 27, 2015·Updated Apr 19, 2017

In Brief

A Phase 3 clinical trial evaluating GFF MDI (PT003) with Aerochamber and GFF MDI (PT003) without Aerochamber for COPD. Completed, enrolled 80 participants across 6 sites.

Detailed Summary

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 27, 2015
Enrollment StartMay 1, 2015
Primary CompletionMar 25, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.1 years ago

Interventions

GFF MDI (PT003) with Aerochamberdevice

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber

GFF MDI (PT003) without Aerochamberdevice

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber