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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-09

Study Completion Date

2018-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)

Group Type EXPERIMENTAL

GFF MDI (PT003)

Intervention Type DRUG

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)

Placebo MDI

Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Group Type PLACEBO_COMPARATOR

Placebo MDI

Intervention Type DRUG

Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Interventions

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GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)

Intervention Type DRUG

Placebo MDI

Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No