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

Phase 3

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: BGF 320/14.4/9.6 µg MDI; Drug: BFF 320/9.6 µg

• Registration Number: NCT03081247
• Lead Sponsor: Pearl Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2018-04-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGF 320/14.4/9.6 µg MDI BID	BGF 320/14.4/9.6 µg MDI	Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
BFF 320/9.6 µg MDI BID	BFF 320/9.6 µg	Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)	Week 12

Secondary Outcome Measures

Name	Time	Method
Peak change from baseline in FEV1	Week 12
Change from baseline in average daily rescue Ventolin HFA use	12 weeks
Time to onset of action	Day 1
Change from baseline in morning pre-dose trough FEV1	Week 12
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)	Week 12
Time to first clinically important deterioration (CID) in COPD	12 weeks
Peak change from baseline in inspiratory capacity	Week 12