To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT ID: NCT03081247

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2018-12-07

Brief Summary

This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

Detailed Description

This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BGF 320/14.4/9.6 µg MDI BID

Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

Group Type: EXPERIMENTAL

BGF 320/14.4/9.6 µg MDI

Intervention Type: DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

BFF 320/9.6 µg MDI BID

Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Group Type: EXPERIMENTAL

BFF 320/9.6 µg

Intervention Type: DRUG

Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Interventions

BGF 320/14.4/9.6 µg MDI

Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

Intervention Type: DRUG

BFF 320/9.6 µg

Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Intervention Type: DRUG

Other Intervention Names

PT010; PT009

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent
• Subjects with an established clinical history of COPD
• Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <80% predicted normal value
• All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking
• Women of Non-childbearing potential
• Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently

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
• Current diagnosis of asthma
• Uncontrolled sleep apnea
• Other Serious Respiratory Disorders
• Hospitalized due to poorly controlled COPD within 6 weeks
• Poorly Controlled COPD
• Immune deficiency and/or severe neurological disorders affecting control of the upper airway
• Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Reisner, MD

Role: STUDY_DIRECTOR

Pearl Therapeutics, Inc.

Other Identifiers

PT010017

Identifier Type: -

Identifier Source: org_study_id