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

Study identifier:PT001102

ClinicalTrials.gov identifier:NCT03358147

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

asthma

Phase

Phase 2/3

Healthy volunteers

No

Study drug

GP MDI 28.8 μg, GP MDI 28.8 μg, GP MDI 14.4 μg, GP MDI 14.4 μg, GP MDI 7.2 μg, GP MDI 7.2 μg, Placebo MDI, Placebo MDI, Spiriva Respimat 2.5 μg, Spiriva Respimat 2.5 μg

Sex

All

Actual enrollment

1077

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 13 Dec 2017
Primary Completion Date: 12 Sept 2019
Study Completion Date: 12 Sept 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2020 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria