Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02685293
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02685293
Study Brief:
Protocol Section:
NCT02685293