PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

Pearl Therapeutics, Inc.140 enrolled

Overview

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

PT001 MDIDRUG

Administered as two puffs BID for 14 days

Tiotropium BromideDRUG

Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI

PT001 Placebo 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 inclusion/exclusion criteria as defined in the protocol

Locations (10)

Pearl Investigative Site

Fullerton, California, United States

Pearl Investigative Site

Clearwater, Florida, United States

Pearl Investigative Site

Panama City, Florida, United States

Outcomes

Primary Outcomes

FEV1 AUC0-12

Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.

Time frame: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)

Secondary Outcomes

Peak Change From Baseline in FEV1

Highest value of FEV1 post dose on day 1

Time frame: Day 1

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

Time to Onset of Action (\>10% Improvement in FEV1) on Day 1.

Time frame: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)

Percentage of Subjects Achieving at Least 12% Improvement in FEV1

Percentage of subjects achieving at least 12% improvement in FEV1.

Time frame: Day 1

Peak Change From Baseline in Inspiratory Capacity (IC)

Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline

Time frame: Day 1 (1 hr and 2 hr post-dose )

Change From Baseline in Morning Pre-dose Trough FEV1

Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)

Time frame: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)

Peak Change From Baseline in FEV1

Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

Data from ClinicalTrials.gov

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Pearl Investigative Site

Tampa, Florida, United States

Pearl Investigative Site

Winter Park, Florida, United States

Pearl Investigative Site

Charlotte, North Carolina, United States

Pearl Investigative Site

Medford, Oregon, United States

Pearl Investigative Site

Spartanburg, South Carolina, United States

Pearl Investigative Site

Longview, Texas, United States

Pearl Investigative Site

Richmond, Virginia, United States

Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)

Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

Time frame: Day 7

Peak Change From Baseline in IC

Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)

Time frame: Day 7 (mean of 1 hr and 2 hr post-dose assessments)

Change From Baseline in Mean Morning Pre-dose Daily PEFR

Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 \[Treatment Day 1\])

Time frame: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)

Change From Baseline in Morning Post-dose Daily PEFR

Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 \[Treatment Day 1\])

Time frame: Day 7 (30 minutes post-dose)

Change From Baseline in Mean Evening Pre-dose PEFR

Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

Time frame: Day 7

Change From Baseline in Mean Evening Post-dose PEFR

Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

Time frame: Day 7

Mean Number of Puffs of Rescue Medication

Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

Time frame: Day 7

Change From Baseline in Morning Pre-dose Trough FEV1

Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)

Time frame: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)

Peak Change From Baseline in FEV1

Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

Time frame: Day 14

Change From Baseline for Mean Morning Pre-dose Trough IC

Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

Time frame: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)

Peak Change From Baseline in IC

Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)

Time frame: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)

Change From Baseline in 12-hour Post-dose Trough FEV1

12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline

Time frame: Day 14 (Baseline, 11.5 and 12 hours post dose)

Change From Baseline in Mean Morning Pre-dose Daily PEFR

Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 \[Treatment 1 Day 1\]

Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

Change From Baseline in Mean Morning Post-dose Daily PEFR

Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 \[Treatment 1 Day 1\]

Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

Change From Baseline in Mean Evening Pre-dose Daily PEFR

Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

Time frame: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)

Change From Baseline in Mean Evening Post-dose Daily PEFR

Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

Time frame: Through the end of the 14-Day Treatment

Mean Number of Puffs of Rescue Medication (End of Treatment)

Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

Time frame: Day 14 (End of treatment)

Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14

Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14

Time frame: Day 1 through Day 14