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Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT02536508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2021-02-26

Study results available
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Summary

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Conditions

Interventions

DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate

DRUG

GFF MDI 14.4/9.6 μg

Glycopyrronium and Formoterol Fumarate

DRUG

BFF MDI 320/9.6 μg

Budesonide and Formoterol Fumarate

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner · Pearl Therapeutics

  • Paul Dorinsky, MD · Pearl Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-10
Primary Completion
2017-09-12
Completion
2017-09-12
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 NCT02536508 on ClinicalTrials.gov