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Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

NCT03256552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-01-23

Study results available
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Summary

The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

Conditions

Interventions

DRUG

Glycopyrronium MDI 28.8 micrograms

Glycopyrronium MDI 28.8 micrograms

DRUG

Glycopyrronium MDI 14.4 micrograms

Glycopyrronium MDI 14.4 micrograms

DRUG

Glycopyrronium MDI 7.2 micrograms

Glycopyrronium MDI 7.2 micrograms

DRUG

Placebo MDI

Placebo Inhalation Aerosol

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-01-28
Primary Completion
2015-09-05
Completion
2015-09-05
FDA Drug
Yes

Countries

  • Japan

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 NCT03256552 on ClinicalTrials.gov