A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared with Symbicort® Turbuhaler® (Kronos) - KRONOS

Study identifier:PT010006

ClinicalTrials.gov identifier:NCT02497001

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared with Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

Study drug

BGF MDI 320/14.4/9.6 μg, GFF MDI (PT003) 14.4/9.6 μg, BFF MDI (PT009) 320/9.6 μg, Symbicort® Turbuhaler® (TBH) Inhalation Powder

Sex

All

Actual Enrollment

1902

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 10 Aug 2015

Primary Completion Date: 05 Jan 2018

Study Completion Date: 05 Jan 2018

Study design

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

Verification:

Verified 01 Dec 2020 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• Given their signed written informed consent to participate.
• 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 inclusion criteria list.

No locations available

Arms	Assigned Interventions
Experimental: BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: BGF MDI 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]) Other Name: BGF
Experimental: GFF MDI (PT003) 14.4/9.6 μg ex-actuator GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol	Drug: GFF MDI (PT003) 14.4/9.6 μg Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI) Other Name: GFF
Experimental: BFF MDI (PT009) 320/9.6 μg ex-actuator BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol	Drug: BFF MDI (PT009) 320/9.6 μg Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI) Other Name: BFF
Active Comparator: Symbicort Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg	-

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Paul Dorinsky

Pearl