A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects with Moderate to Severe COPD

Study identifier:PT003019

ClinicalTrials.gov identifier:NCT02937584

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

Medical condition

COPD, Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

Study drug

GP MDI (PT001) 14.4 μg, FF MDI (PT005) 9.6 μg

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 29 Dec 2016

Primary Completion Date: 28 May 2018

Study Completion Date: 28 May 2018

Study design

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

Verification:

Verified 01 May 2019 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
-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.
− At Visit 1, FEV1/FVC ratio must be <0.70
− At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value,
calculated using The Third National Health and Nutrition Examination Survey
(NHANES III) reference equations.

Exclusion Criteria

-Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject 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.
-Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
-Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
-Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
-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 Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
-Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
-Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

No locations available

Arms	Assigned Interventions
Experimental: GP MDI (PT001) 14.4 μg Glycopyrronium	Drug: GP MDI (PT001) 14.4 μg Glycopyrronium
Experimental: FF MDI (PT005) 9.6 μg Formoterol Fumarate	Drug: FF MDI (PT005) 9.6 μg Formoterol Fumarate

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4186&filename=PT003019-01_FLUI-2015-140_Protocol_10%20August_Redacted_PDFA.pdf
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4186&filename=PT003019-01_FLUI-2015-140_Protocol_10%20August_Redacted_PDFA.pdf
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4186&filename=PT003019-sap-16APR2018-Redacted_PDFA.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Jane Fitzpatrick

973.975.0333

Investigators

Principal Investigator

Chad Orevillo

Pearl Therapeutics