CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,077 enrolled
Drug / intervention
GP MDI 28.8 μg +4 moredrug
Likely dose
GP MDI 28.8 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/NCT03358147
NCT03358147Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Pearl Therapeutics, Inc.·interventional·Posted Nov 30, 2017·Updated Aug 12, 2020

In Brief

A Phase 3 clinical trial evaluating GP MDI 28.8 μg, GP MDI 14.4 μg, and 3 other interventions for Asthma. Completed, enrolled 1,077 participants across 232 sites.

Detailed Summary

Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma

Study Details

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

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 30, 2017
Enrollment StartDec 13, 2017
Primary CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.6 years ago

Interventions

GP MDI 28.8 μgdrug

GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID

GP MDI 14.4 μgdrug

GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID

GP MDI 7.2 μgdrug

GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID

Placebo MDIdrug

Placebo taken as 2 inhalations BID

Spiriva Respimat 2.5 μgdrug

Spiriva Respimat 2.5 μg QD (open-label)