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Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium

NCT00871182•Pearl Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent
•40 - 75 years of age
•Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
•COPD diagnosis
•Current/former smokers with at least a 10 pack-year history of cigarette smoking
•Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
•Must demonstrate reversibility to ipratropium demonstrated by a \>200 mL improvement over baseline and/or \>12% and \>150 mL improvement over baseline
•Patients willing to stay at study site for at least 24 hours on each test day

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 24 weeks of Screening
•Unable to perform acceptable spirometry
•Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
•Clinically significant medical conditions
+22 more criteria

Locations (6)

Pivotal Research Centers

Peoria, Arizona, United States

National Jewish Health

Denver, Colorado, United States

Elite Research Institute

Miami, Florida, United States

Pulmonary and Critical Care Medicine

Omaha, Nebraska, United States

Cincinnati VAMC

Cincinnati, Ohio, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

June 21, 2013

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Inhaled PT001

DRUG

Inhaled Placebo

DRUG

Tiotropium Handihaler

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

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

NCT05878769

Chronic Obstructive Pulmonary Disease

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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: June 21, 2013Data 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.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

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