Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States
      • Pearl Investigative Site
  • California
    • Rancho Mirage, California, United States
      • Pearl Investigative Site
  • Connecticut
    • Waterbury, Connecticut, United States
      • Pearl Investigative Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • Pearl Investigative Site
    • Clearwater, Florida, United States
      • Pearl Investigative Site
    • Pensacola, Florida, United States
      • Pearl Investigative Site
    • Winter Park, Florida, United States, 32789
      • Pearl Investigative Site
  • Louisiana
    • Lafayette, Louisiana, United States
      • Pearl Investigative Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • Pearl Investigative Site
  • Minnesota
    • Fridley, Minnesota, United States
      • Pearl Investigative Site
  • Missouri
    • St. Louis, Missouri, United States
      • Pearl Investigative Site
  • New Jersey
    • Summit, New Jersey, United States
      • Pearl Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Pearl Investigative Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Pearl Investigative Site
    • Medford, Oregon, United States
      • Pearl Investigative Site
  • South Carolina
    • Rock Hill, South Carolina, United States
      • Pearl Investigative Site
    • Spartanburg, South Carolina, United States, 29303
      • Pearl Investigative Site
  • Texas
    • San Antonio, Texas, United States
      • Pearl Investigative Site
  • West Virginia
    • Morgantown, West Virginia, 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 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

8

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: PT003 (Dose 5); PT003 MDI Dose 5	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
Active Comparator: Spiriva® Handihaler®; Tiotropium Bromide	Drug: Tiotropium inhalation powder; Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 AUC 0-12 on Day 7	FEV1 AUC 0-12	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Change From Baseline in FEV1 on Treatment Day 1	Peak change from Baseline in FEV1 on Treatment	Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1	Time to onset of action (>10% improvement in FEV1)	Day 1
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	Proportion of subjects achieving >=12% improvement in FEV1	Day 1
Peak Change From Baseline in Inspiratory Capacity on Day 1	Peak change from baseline in Inspiratory Capacity	Day 1
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	Change from baseline in morning pre-dose trough FEV1	Day 7
Peak Change From Baseline in FEV1 on Day 7	Peak change from baseline in FEV1 Day 7	Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7	Change from baseline in morning pre-dose trough IC	Day 7
Peak Change From Baseline IC on Day 7	Peak change from baseline IC	Day 7
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	Change from baseline at evening 12-hour post-dose trough FEV1	Day 7
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	Change from baseline in mean morning pre-dose daily peak flow readings	Day 7
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	Change from baseline in mean morning post-dose daily peak flow readings on	Day 7
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)	Day 7
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)	Day 7

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 27, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: PT003005

Drug and device information, study documents

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