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

Study identifier:PT003017

ClinicalTrials.gov identifier:NCT02685293

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared with Placebo

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

Study drug

GFF MDI (PT003), Placebo MDI

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 09 Dec 2016

Primary Completion Date: 06 Jun 2018

Study Completion Date: 06 Jun 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2019 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: GFF MDI (PT003) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)	Drug: GFF MDI (PT003) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Placebo Comparator: Placebo MDI Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol	Drug: Placebo MDI Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4146&filename=PT003017_CSP_V3_Redacted_coverpage_PDFA.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics