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PT003 MDI Dose Confirmation Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PT003
PT001
PT005
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 (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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PT003 (Dose 1)

PT003 (Dose 2)

PT003 (Dose 3)

PT003 (Dose 4)

PT001

PT005

Arm Description

PT003 MDI Dose 1

PT003 MDI Dose 2

PT003 MDI Dose 3

PT003 MDI Dose 4

PT001 MDI

PT005 MDI

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2011
Last Updated
April 26, 2017
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01349816
Brief Title
PT003 MDI Dose Confirmation Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (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 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).

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
185 (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
PT001
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT005
Arm Type
Experimental
Arm Description
PT005 MDI
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
Primary Outcome Measure Information:
Title
FEV1 AUC0-12
Description
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Peak Change From Baseline in FEV1
Description
Peak change from baseline in FEV1 through 2 hours
Time Frame
Day 1
Title
Time to Onset of Action
Description
At least 10% improvement in mean FEV1
Time Frame
Day 1
Title
At Least 12% Improvement in FEV1
Description
Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline
Time Frame
Day 1
Title
Peak Change in IC
Description
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
Time Frame
Day 1
Title
Morning Pre-dose FEV1
Description
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Time Frame
Day 7
Title
FEV1 Through 6 Hours
Description
Peak change from baseline in FEV1 through 6 hours
Time Frame
Day 7
Title
Peak Change From Baseline in IC
Description
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Time Frame
Day 7
Title
Mean Evening Trough FEV1
Description
Change from baseline in mean evening 12-hour post-dose trough FEV1
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, M.D.
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Rancho Mirage
State/Province
California
Country
United States
Facility Name
Pearl Investigative Site
City
Colorado Springs
State/Province
Colorado
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
Country
United States
Facility Name
Pearl Investigative Site
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Pearl Investigative Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Pearl Investigative Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Pearl Investigative Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pearl Investigative Site
City
Winston-Salem
State/Province
North Carolina
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
Country
United States
Facility Name
Pearl Investigative Site
City
Spartanburg
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29950826
Citation
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.
Results Reference
derived

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PT003 MDI Dose Confirmation Study

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