Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects with COPD compared with Symbicort® Turbohaler®

Study identifier:PT010007

ClinicalTrials.gov identifier:NCT03262012

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbuhaler® as an Active Control

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

Study drug

BGF MDI (PT010), GFF MDI (PT003), BFF MDI (PT009), Symbicort® Turbohaler® Inhalation Powder

Sex

All

Actual Enrollment

416

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 09 Aug 2016

Primary Completion Date: 15 Jun 2018

Study Completion Date: 15 Jun 2018

Study design

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

Verification:

Verified 01 Apr 2020 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

•Given their signed written informed consent to participate.
•Subjects must have agreed to participate and complete the lead-in Study PT010006.
•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 serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
•Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
•Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
•Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
•Required COPD maintenance therapy:
•All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies.
Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

•Significant diseases or conditions other than COPD, 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 Screening Period
•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 Screening Period
•Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
•Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
•Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
Please refer to the study protocol for the complete exclusion criteria list.

No locations available

Arms	Assigned Interventions
Experimental: BGF MDI (PT010) Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010	Drug: BGF MDI (PT010) Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 Other Name: BGF
Experimental: GFF MDI (PT003) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003	Drug: GFF MDI (PT003) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 Other Name: GFF
Experimental: BFF MDI (PT009) Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009	Drug: BFF MDI (PT009) Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 Other Name: BFF
Active Comparator: Symbicort® Turbohaler® Inhalation Powder Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler	Drug: Symbicort® Turbohaler® Inhalation Powder Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler Other Name: Symbicort

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Paul M. Dorinsky

Pearl Therapeutics, Inc.