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PT003 MDI Cardiovascular Safety Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2

PT003 MDI Cardiovascular Safety Study

A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01349803•Pearl Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent
•40 - 80 years of age
•Clinical history of COPD with airflow limitation that is not fully reversible
•Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
•Current/former smokers with at least a 10 pack-year history of cigarette smoking
•A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
•A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
•Able to change COPD treatment as required by protocol
•Acceptable baseline (Visit 2) Holter monitor recording

Exclusion Criteria

•Women who are pregnant or lactating
•Primary diagnosis of asthma
•Alpha-1 antitrypsin deficiency as the cause of COPD
•Active pulmonary diseases
•Prior lung volume reduction surgery
•Abnormal chest X-ray (or CT scan) not due to the presence of COPD
•Hospitalized due to poorly controlled COPD within 3 months of Screening
•Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
•Cancer that has not been in complete remission for at least 5 years
•Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
+2 more criteria

Locations (20)

Pearl Investigative Site

Glendale, Arizona, United States

Pearl Investigative Site

Fullerton, California, United States

Pearl Investigative Site

Los Angeles, California, United States

Pearl Investigative Site

San Diego, California, United States

Pearl Investigative Site

Pensacola, Florida, United States

Pearl Investigative Site

Lafayette, Louisiana, United States

Pearl Investigative Site

North Dartmouth, Massachusetts, United States

Pearl Investigative Site

Livonia, Michigan, United States

Pearl Investigative Site

Medford, Oregon, United States

Pearl Investigative Site

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

January 31, 2017

Enrollment

237

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

PT005 MDI

DRUG

PT001 MDI

DRUG

PT003 MDI

DRUG

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PT003 MDI Cardiovascular Safety Study

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease