NCT03358147

Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,077 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	GP MDI 28.8 μg	GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
DRUG	GP MDI 14.4 μg	GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
DRUG	GP MDI 7.2 μg	GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
DRUG	Placebo MDI	Placebo taken as 2 inhalations BID
DRUG	Spiriva Respimat 2.5 μg	Spiriva Respimat 2.5 μg QD (open-label)

Timeline

• Start date: 2017-12-13
• Primary completion: 2019-09-12
• Completion: 2019-09-12
• First posted: 2017-11-30
• Last updated: 2020-08-12
• Results posted: 2020-08-12

Locations

232 sites across 1 country: United States

Regulatory

• FDA-regulated drug study