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

NCT03358147 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1077

Last updated 2020-08-12

Study results available
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Summary

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2019-09-12
Completion
2019-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03358147 on ClinicalTrials.gov