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 14.4 μg, GP MDI 7.2 μg, Placebo MDI, 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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: GP MDI 28.8 μg GP MDI 14.4 μg per actuation taken as 2 inhalations BID | Drug: GP MDI 28.8 μg GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID Other Name: GP |
| Experimental: GP MDI 14.4 μg GP MDI 7.2 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 Other Name: GP |
| Experimental: GP MDI 7.2 μg GP MDI 3.6 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 Other Name: GP |
| Placebo Comparator: Placebo MDI Taken as 2 inhalations BID | Drug: Placebo MDI Placebo taken as 2 inhalations BID Other Name: Placebo |
| Other: Spiriva Respimat 2.5 μg Open Label Spiriva Respimat 2.5 μg | Drug: Spiriva Respimat 2.5 μg Spiriva Respimat 2.5 μg QD (open-label) Other Name: Spiriva Respimat |
