Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

Pearl Therapeutics, Inc.1,756 enrolled

Overview

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,756

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

GFF MDI (PT003)DRUG

Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

FF MDI (PT005)DRUG

Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

GP MDI (PT001)DRUG

Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). * Current or former smokers with a history of at least 10 pack-years of cigarette smoking. * Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of \<0.70. * FEV1 must be \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions). Exclusion Criteria: * Significant diseases other than COPD, ie, disease or condition 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 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 (Visit 1 to Visit 4). * 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 (Visit 1 to Visit 4). * Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible. * Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Locations (166)

Outcomes

Primary Outcomes

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)

For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment

Time frame: at week 24

Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach

Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach

Time frame: over weeks 12-24

Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.

Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.

Time frame: over 24 weeks

Secondary Outcomes

TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach

TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9

Time frame: over 24 Weeks

TDI Focal Score Over Weeks 12-24 Japan Approach

TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9

Data from ClinicalTrials.gov

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Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)

Research Site

Andalusia, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Foley, Alabama, United States

Research Site

Jasper, Alabama, United States

Research Site

Anaheim, California, United States

Research Site

Boulder, Colorado, United States

Research Site

Clearwater, Florida, United States

Research Site

Clearwater, Florida, United States

Research Site

Kissimmee, Florida, United States

Research Site

Miami, Florida, United States

...and 156 more locations

Time frame: over Weeks 12-24

TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population

Time frame: over 24 Weeks

TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population

Time frame: over weeks 12-24

Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach

Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach

Time frame: at week 24

Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach

Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach

Time frame: over weeks 12-24

Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach

Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach

Time frame: over 24 weeks

Change From Baseline in SGRQ Total Score at Week 24, US/China Approach

Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life

Time frame: at week 24

Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach

Time frame: over weeks 12-24

Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach

Time frame: at week 24

Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach

Time frame: over weeks 12-24

Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches

Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches

Time frame: over 24 weeks

FEV1 Measured at 5 Minutes Post-dose on Day 1

Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant

Time frame: Assessed at 5-minutes post dose on Day 1

FEV1 Measured at 15 Minutes Post-dose on Day 1

Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant

Time frame: Assessed at 15-minute post dose on Day 1