PT003 MDI Dose Confirmation Study

A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: PT003; Drug: PT001; Drug: PT005

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Rancho Mirage, California, United States
      • Pearl Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • Pearl Investigative Site
  • Connecticut
    • Waterbury, Connecticut, United States
      • Pearl Investigative Site
  • Florida
    • Clearwater, Florida, United States
      • Pearl Investigative Site
    • Pensacola, Florida, United States
      • Pearl Investigative Site
  • Georgia
    • Stockbridge, Georgia, United States
      • Pearl Investigative Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Pearl Investigative Site
  • New York
    • Brooklyn, New York, United States
      • Pearl Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States
      • Pearl Investigative Site
    • Winston-Salem, North Carolina, United States
      • Pearl Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Pearl Investigative Site
  • Oregon
    • Medford, Oregon, United States
      • Pearl Investigative Site
  • South Carolina
    • Spartanburg, South Carolina, United States
      • Pearl Investigative Site

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 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

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT003 (Dose 1); PT003 MDI Dose 1	Drug: PT003; PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 2); PT003 MDI Dose 2	Drug: PT003; PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 3); PT003 MDI Dose 3	Drug: PT003; PT003 MDI administered as two puffs BID for 7 days
Experimental: PT003 (Dose 4); PT003 MDI Dose 4	Drug: PT003; PT003 MDI administered as two puffs BID for 7 days
Experimental: PT001; PT001 MDI	Drug: PT001; PT001 MDI administered as two puffs BID for 7 days
Experimental: PT005; PT005 MDI	Drug: PT005; PT005 MDI administered as two puffs BID for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 AUC0-12	Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Change From Baseline in FEV1	Peak change from baseline in FEV1 through 2 hours	Day 1
Time to Onset of Action	At least 10% improvement in mean FEV1	Day 1
At Least 12% Improvement in FEV1	Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline	Day 1
Peak Change in IC	Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline	Day 1
Morning Pre-dose FEV1	Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)	Day 7
FEV1 Through 6 Hours	Peak change from baseline in FEV1 through 6 hours	Day 7
Peak Change From Baseline in IC	Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)	Day 7
Mean Evening Trough FEV1	Change from baseline in mean evening 12-hour post-dose trough FEV1	Day 7

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Reisner C, Pearle J, Kerwin EM, Rose ES, Darken P. Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Jun 19;13:1965-1977. doi: 10.2147/COPD.S166455. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: PT003004