CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Glycopyrronium MDI 28.8 micrograms +3 moredrug
Likely dose
Glycopyrronium MDI 28.8 microgramsfrom 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/NCT03256552
NCT03256552Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

Pearl Therapeutics, Inc.·interventional·Posted Aug 22, 2017·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating Glycopyrronium MDI 28.8 micrograms, Glycopyrronium MDI 14.4 micrograms, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 66 participants across 18 sites.

Detailed Summary

The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 22, 2017
Enrollment StartJan 28, 2015
Primary CompletionSep 5, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.9 years ago

Interventions

Glycopyrronium MDI 28.8 microgramsdrug

Glycopyrronium MDI 28.8 micrograms

Glycopyrronium MDI 14.4 microgramsdrug

Glycopyrronium MDI 14.4 micrograms

Glycopyrronium MDI 7.2 microgramsdrug

Glycopyrronium MDI 7.2 micrograms

Placebo MDIdrug

Placebo Inhalation Aerosol