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Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

NCT01854645•Pearl Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
•Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
•Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
•Average f the -60 and the -30 min pre-dose FEV1 assessments must be \< 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
•Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Exclusion Criteria

•Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
•Current diagnosis of asthma or alpha-1 antitrypsin deficiency
•Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
•Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
•Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
•Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
•Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
•Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
•Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
•Clinically significant abnormal 12-lead ECG
+3 more criteria

Locations (139)

Pearl Investigative Site

Andalusia, Alabama, United States

Pearl Investigative Site

Anniston, Alabama, United States

Pearl Investigative Site

Athens, Alabama, United States

Pearl Investigative Site

Birmingham, Alabama, United States

Pearl Investigative Site

Mesa, Arizona, United States

Pearl Investigative Site

Phoenix, Arizona, United States

Pearl Investigative Site

Scottsdale, Arizona, United States

Pearl Investigative Site

Tucson, Arizona, United States

Pearl Investigative Site

Anaheim, California, United States

Pearl Investigative Site

Carlsbad, California, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

March 28, 2017

Enrollment

2,103

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

GFF MDI

DRUG

GP MDI

DRUG

FF MDI

DRUG

Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

DRUG

Placebo MDI

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

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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: March 28, 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.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

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

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