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PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PT001 MDI
Ipratropium Bromide HFA Inhalation Aerosol
Placebo MDI
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

PT001 MDI (Dose 1)

PT001 MDI (Dose 2)

PT001 MDI (Dose 3)

PT001 MDI (Dose 4)

Ipratropium Bromide HFA Inhalation Aerosol

Placebo MDI

Arm Description

PT001 MDI

PT001 MDI

PT001 MDI

PT001 MDI

Ipratropium Bromide HFA Inhalation Aerosol

PT001 Placebo MDI

Outcomes

Primary Outcome Measures

FEV1 AUC0-12
FEV1 AUC0-12 following chronic dosing (1 week), normalized.

Secondary Outcome Measures

Peak Change From Baseline in FEV1 on Day 1
Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
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 at Least 12% Improvement in FEV1 on Day 1
Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Peak Change From Baseline in IC on Day 1
Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Change from baseline in morning pre-dose FEV1
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1
Peak Change From Baseline in IC on Day 7
Peak change from baseline in IC
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
Change from baseline in 12-hour post-dose trough FEV1

Full Information

First Posted
May 5, 2011
Last Updated
May 23, 2018
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01350128
Brief Title
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2011 (Actual)
Primary Completion Date
October 1, 2011 (Actual)
Study Completion Date
October 1, 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 overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Detailed Description
The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

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
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PT001 MDI (Dose 1)
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT001 MDI (Dose 2)
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT001 MDI (Dose 3)
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
PT001 MDI (Dose 4)
Arm Type
Experimental
Arm Description
PT001 MDI
Arm Title
Ipratropium Bromide HFA Inhalation Aerosol
Arm Type
Active Comparator
Arm Description
Ipratropium Bromide HFA Inhalation Aerosol
Arm Title
Placebo MDI
Arm Type
Placebo Comparator
Arm Description
PT001 Placebo MDI
Intervention Type
Drug
Intervention Name(s)
PT001 MDI
Intervention Description
PT001 MDI administered as two puffs BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Ipratropium Bromide HFA Inhalation Aerosol
Other Intervention Name(s)
Atrovent
Intervention Description
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
Intervention Type
Other
Intervention Name(s)
Placebo MDI
Intervention Description
Matching placebo to PT001 MDI administered as two puffs BID for 7 days
Primary Outcome Measure Information:
Title
FEV1 AUC0-12
Description
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
Time Frame
Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Secondary Outcome Measure Information:
Title
Peak Change From Baseline in FEV1 on Day 1
Description
Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
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 (15 min, 30 min, 1 hour, 2 hours)
Title
Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1
Description
Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
Time Frame
Day 1
Title
Peak Change From Baseline in IC on Day 1
Description
Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)
Time Frame
Day 1
Title
Change From Baseline in Morning Pre-dose FEV1 on Day 7
Description
Change from baseline in morning pre-dose FEV1
Time Frame
Day 7
Title
Peak Change From Baseline in FEV1 on Day 7
Description
Peak change from baseline in FEV1
Time Frame
Day 7
Title
Peak Change From Baseline in IC on Day 7
Description
Peak change from baseline in IC
Time Frame
Day 7
Title
Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7
Description
Change from baseline in 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
Panama City
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Pearl Investigative Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Pearl Investigative Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
Pearl Investigative Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Pearl Investigative Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Pearl Investigative Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29506504
Citation
Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4164&filename=PT001002-00_Protocol_Redacted_23JAN2018.pdf
Description
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PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

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