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

A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: BGF 320/14.4/9.6 µg MDI; Drug: BFF 320/9.6 µg

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGF 320/14.4/9.6 µg MDI BID; Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)	Drug: BGF 320/14.4/9.6 µg MDI; Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI); Other Names: PT010
Experimental: BFF 320/9.6 µg MDI BID; Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)	Drug: BFF 320/9.6 µg; Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI); Other Names: PT009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to onset of action	Day 1
Change from baseline in morning pre-dose trough FEV1	Week 12
Peak change from baseline in inspiratory capacity	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
Change from baseline in average daily rescue Ventolin HFA use	12 weeks
Peak change from baseline in FEV1	Week 12

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Study Director: Colin Reisner, MD, Pearl Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 16, 2018
• Primary Completion (Anticipated): December 7, 2018
• Study Completion (Anticipated): December 7, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PT010017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes