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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PT003
PT001
PT005
Tiotropium inhalation powder
Sponsored by
Pearl Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site
  • Pearl Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

PT003 (Dose 1)

PT003 (Dose 2)

PT003 (Dose 3)

PT003 (Dose 4)

PT003 (Dose 5)

PT001

PT005

Spiriva® Handihaler®

Arm Description

PT003 MDI Dose 1

PT003 MDI Dose 2

PT003 MDI Dose 3

PT003 MDI Dose 4

PT003 MDI Dose 5

PT001 MDI

PT005 MDI

Tiotropium Bromide

Outcomes

Primary Outcome Measures

FEV1 AUC 0-12 on Day 7
FEV1 AUC 0-12

Secondary Outcome Measures

Peak Change From Baseline in FEV1 on Treatment Day 1
Peak change from Baseline in FEV1 on Treatment
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time to onset of action (>10% improvement in FEV1)
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Proportion of subjects achieving >=12% improvement in FEV1
Peak Change From Baseline in Inspiratory Capacity on Day 1
Peak change from baseline in Inspiratory Capacity
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Change from baseline in morning pre-dose trough FEV1
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1 Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7
Change from baseline in morning pre-dose trough IC
Peak Change From Baseline IC on Day 7
Peak change from baseline IC
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
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
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
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)
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)

Full Information

First Posted
April 25, 2012
Last Updated
May 23, 2016
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01587079
Brief Title
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PT003 (Dose 1)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 1
Arm Title
PT003 (Dose 2)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 2
Arm Title
PT003 (Dose 3)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 3
Arm Title
PT003 (Dose 4)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 4
Arm Title
PT003 (Dose 5)
Arm Type
Experimental
Arm Description
PT003 MDI Dose 5
Arm Title
PT001
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT005
Arm Type
Experimental
Arm Description
PT005 MDI
Arm Title
Spiriva® Handihaler®
Arm Type
Active Comparator
Arm Description
Tiotropium Bromide
Intervention Type
Drug
Intervention Name(s)
PT003
Intervention Description
PT003 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
PT001
Intervention Description
PT001 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
PT005
Intervention Description
PT005 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Tiotropium inhalation powder
Intervention Description
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days
Primary Outcome Measure Information:
Title
FEV1 AUC 0-12 on Day 7
Description
FEV1 AUC 0-12
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Peak Change From Baseline in FEV1 on Treatment Day 1
Description
Peak change from Baseline in FEV1 on Treatment
Time Frame
Day 1
Title
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Description
Time to onset of action (>10% improvement in FEV1)
Time Frame
Day 1
Title
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Description
Proportion of subjects achieving >=12% improvement in FEV1
Time Frame
Day 1
Title
Peak Change From Baseline in Inspiratory Capacity on Day 1
Description
Peak change from baseline in Inspiratory Capacity
Time Frame
Day 1
Title
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Description
Change from baseline in morning pre-dose trough FEV1
Time Frame
Day 7
Title
Peak Change From Baseline in FEV1 on Day 7
Description
Peak change from baseline in FEV1 Day 7
Time Frame
Day 7
Title
Change From Baseline in Morning Pre-dose Trough IC on Day 7
Description
Change from baseline in morning pre-dose trough IC
Time Frame
Day 7
Title
Peak Change From Baseline IC on Day 7
Description
Peak change from baseline IC
Time Frame
Day 7
Title
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
Description
Change from baseline at evening 12-hour post-dose trough FEV1
Time Frame
Day 7
Title
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
Description
Change from baseline in mean morning pre-dose daily peak flow readings
Time Frame
Day 7
Title
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
Description
Change from baseline in mean morning post-dose daily peak flow readings on
Time Frame
Day 7
Title
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
Description
Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Time Frame
Day 7
Title
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
Description
Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, MD
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Pearl Investigative Site
City
Rancho Mirage
State/Province
California
Country
United States
Facility Name
Pearl Investigative Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Pearl Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Pearl Investigative Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Pearl Investigative Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
Pearl Investigative Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Pearl Investigative Site
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Pearl Investigative Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Pearl Investigative Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
Pearl Investigative Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pearl Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Pearl Investigative Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Pearl Investigative Site
City
Rock Hill
State/Province
South Carolina
Country
United States
Facility Name
Pearl Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Pearl Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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