Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COPD

In brief

This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD.

Key facts

Study ID

NCT02685293

Run by

Pearl Therapeutics, Inc.

People needed

4

Starts

2016-12-09

Expected to finish

2018-06-06

Last updated by the study team

2019-08-28

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 40 years of age and no older than 80 at Visit 1.
• Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit
• Evidence of lung hyperinflation
• 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.
• Pre- and Post-bronchodilator FEV1/FVC ratio must be <0.70
• Post-bronchodilator FEV1 must be ≥30% to <65% predicted normal value, calculated using NHANES III reference equations.

You may not qualify if…

• Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk
• Women who are pregnant or lactating or are planning to become pregnant during the course of the study
• Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease
• Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening
• Subjects who have 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
• Subjects who have clinically significant uncontrolled hypertension.
• Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator.
• Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
• Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit 2.
• Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2
• Subjects who have cancer that has not been in complete remission for at least five years.
• Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated.
• Subjects with a clinically significant ECG
• Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl.

Where it is running

• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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