Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Pearl Therapeutics, Inc.118 enrolled

Overview

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

118

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

PT003 MDIDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written informed consent * 40 - 80 years of age * Clinical history of COPD with airflow limitation that is not fully reversible * Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * Current/former smokers with at least a 10 pack-year history of cigarette smoking * A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70 * A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * Able to change COPD treatment as required by protocol Exclusion Criteria: * Women who are pregnant or lactating * Primary diagnosis of asthma * Alpha-1 antitrypsin deficiency as the cause of COPD * Active pulmonary diseases * Prior lung volume reduction surgery * Abnormal chest X-ray (or CT scan) not due to the presence of COPD * Hospitalized due to poorly controlled COPD within 3 months of Screening * Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * Cancer that has not been in complete remission for at least 5 years * Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives Other protocol defined inclusion/exclusion criteria may apply

Locations (16)

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

American Health Research

Charlotte, North Carolina, United States

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Austrials

Caringbah, New South Wales, Australia

Woolcock

Glebe, New South Wales, Australia

Austrials

Hornsby, New South Wales, Australia

Austrials

Auchenflower, Queensland, Australia

Q-Pharm

Herston, Queensland, Australia

Respiratory Research Foundation - Burnside War Memorial Hospital

Adelaide, South Australia, Australia

...and 6 more locations

Outcomes

Primary Outcomes

FEV1 AUC 0-12 on Day 7

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration

Time frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7

Secondary Outcomes

Peak Change From BL in FEV1 on Day 1

Peak change from Baseline in FEV1 on Day 1

Time frame: Day 1

Peak Change From BL in FEV1 on Day 7

Peak change from Baseline (BL) in FEV1 on Day 7

Time frame: Day 7

Peak Change From BL in Inspiratory Capacity on Day 1

Peak change from Baseline in Inspiratory Capacity (IC) on Day 1

Time frame: Day 1

Peak Change From BL IC on Day 7

Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration

Time frame: Day 7

Time to Onset of Action >=10% Improvement in FEV1 on Day 1

Time to Onset of Action where the improvement in FEV1 on Day 1 was \>=10%

Time frame: Day 1

Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1

Time to Onset of Action where the improvement in FEV1 on Day 1 was \>= 12%

Time frame: Day 1

Change in Morning Pre-dose FEV1 on Day 7

Change from Baseline in morning pre-dose FEV1 on Day 7

Time frame: Day 7

12 hr Post-dose Trough FEV1 on Day 7

12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7

Time frame: Day 7

Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7

Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7

Time frame: Day 7

Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7

Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7

Time frame: Day 7

Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7

Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7

Time frame: Day 7

Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7

Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7

Time frame: Day 7