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PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PT001 MDI
Tiotropium Bromide
PT001 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

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

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

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

Placebo Comparator

Active Comparator

Arm Label

PT001 MDI (Dose 1)

PT001 MDI (Dose 2)

PT001 MDI (Dose 3)

PT001 MDI (Dose 4)

PT001 MDI (Dose 5)

PT001 MDI (Dose 6)

PT001 Placebo MDI

Spiriva® Handihaler® (Tiotropium Bromide)

Arm Description

Outcomes

Primary Outcome Measures

FEV1 AUC0-12
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.

Secondary Outcome Measures

Peak Change From Baseline in FEV1
Highest value of FEV1 post dose on day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1.
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Percentage of subjects achieving at least 12% improvement in FEV1.
Peak Change From Baseline in Inspiratory Capacity (IC)
Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline
Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Peak Change From Baseline in IC
Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Change From Baseline in Morning Post-dose Daily PEFR
Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Change From Baseline in Mean Evening Pre-dose PEFR
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Change From Baseline in Mean Evening Post-dose PEFR
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Mean Number of Puffs of Rescue Medication
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Change From Baseline for Mean Morning Pre-dose Trough IC
Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Peak Change From Baseline in IC
Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)
Change From Baseline in 12-hour Post-dose Trough FEV1
12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Change From Baseline in Mean Morning Post-dose Daily PEFR
Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Change From Baseline in Mean Evening Pre-dose Daily PEFR
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Change From Baseline in Mean Evening Post-dose Daily PEFR
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Mean Number of Puffs of Rescue Medication (End of Treatment)
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14

Full Information

First Posted
March 27, 2012
Last Updated
October 10, 2017
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01566773
Brief Title
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Official Title
A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 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 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 assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP 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
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PT001 MDI (Dose 1)
Arm Type
Experimental
Arm Title
PT001 MDI (Dose 2)
Arm Type
Experimental
Arm Title
PT001 MDI (Dose 3)
Arm Type
Experimental
Arm Title
PT001 MDI (Dose 4)
Arm Type
Experimental
Arm Title
PT001 MDI (Dose 5)
Arm Type
Experimental
Arm Title
PT001 MDI (Dose 6)
Arm Type
Experimental
Arm Title
PT001 Placebo MDI
Arm Type
Placebo Comparator
Arm Title
Spiriva® Handihaler® (Tiotropium Bromide)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PT001 MDI
Intervention Description
Administered as two puffs BID for 14 days
Intervention Type
Drug
Intervention Name(s)
Tiotropium Bromide
Other Intervention Name(s)
Spiriva® Handihaler®
Intervention Description
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Intervention Type
Drug
Intervention Name(s)
PT001 Placebo MDI
Primary Outcome Measure Information:
Title
FEV1 AUC0-12
Description
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
Time Frame
Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Secondary Outcome Measure Information:
Title
Peak Change From Baseline in FEV1
Description
Highest value of FEV1 post dose on day 1
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) on Day 1.
Time Frame
Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)
Title
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Description
Percentage of subjects achieving at least 12% improvement in FEV1.
Time Frame
Day 1
Title
Peak Change From Baseline in Inspiratory Capacity (IC)
Description
Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline
Time Frame
Day 1 (1 hr and 2 hr post-dose )
Title
Change From Baseline in Morning Pre-dose Trough FEV1
Description
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Time Frame
Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Title
Peak Change From Baseline in FEV1
Description
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Time Frame
Day 7
Title
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
Description
Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Time Frame
Day 7
Title
Peak Change From Baseline in IC
Description
Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)
Time Frame
Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Title
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Description
Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Time Frame
Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
Title
Change From Baseline in Morning Post-dose Daily PEFR
Description
Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Time Frame
Day 7 (30 minutes post-dose)
Title
Change From Baseline in Mean Evening Pre-dose PEFR
Description
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Time Frame
Day 7
Title
Change From Baseline in Mean Evening Post-dose PEFR
Description
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Time Frame
Day 7
Title
Mean Number of Puffs of Rescue Medication
Description
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Time Frame
Day 7
Title
Change From Baseline in Morning Pre-dose Trough FEV1
Description
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Time Frame
Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Title
Peak Change From Baseline in FEV1
Description
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Time Frame
Day 14
Title
Change From Baseline for Mean Morning Pre-dose Trough IC
Description
Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Time Frame
Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Title
Peak Change From Baseline in IC
Description
Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)
Time Frame
Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Title
Change From Baseline in 12-hour Post-dose Trough FEV1
Description
12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline
Time Frame
Day 14 (Baseline, 11.5 and 12 hours post dose)
Title
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Description
Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Time Frame
Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Title
Change From Baseline in Mean Morning Post-dose Daily PEFR
Description
Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Time Frame
Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Title
Change From Baseline in Mean Evening Pre-dose Daily PEFR
Description
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Time Frame
Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Title
Change From Baseline in Mean Evening Post-dose Daily PEFR
Description
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Time Frame
Through the end of the 14-Day Treatment
Title
Mean Number of Puffs of Rescue Medication (End of Treatment)
Description
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Time Frame
Day 14 (End of treatment)
Title
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Description
Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Time Frame
Day 1 through Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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, MD
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
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
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Pearl Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
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
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
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
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Pearl Investigative Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Pearl Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27586537
Citation
Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4161&filename=protocol-pt001003_FINAL_Redacted.pdf
Description
protocol-pt001003_FINAL_Redacted

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PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

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