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

October 10, 2017 updated by: Pearl Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835
        • Pearl Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Pearl Investigative Site
      • Panama City, Florida, United States, 32405
        • Pearl Investigative Site
      • Tampa, Florida, United States, 33603
        • Pearl Investigative Site
      • Winter Park, Florida, United States, 32789
        • Pearl Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pearl Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Pearl Investigative Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Pearl Investigative Site
    • Texas
      • Longview, Texas, United States, 75605
        • Pearl Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Pearl Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PT001 MDI (Dose 1)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 2)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 3)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 4)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 5)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 6)
Drug: PT001 MDI
Administered as two puffs BID for 14 days
Placebo Comparator: PT001 Placebo MDI
Drug: PT001 Placebo MDI
Active Comparator: Spiriva® Handihaler® (Tiotropium Bromide)
Drug: Tiotropium Bromide
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Other Names:
  • Spiriva® Handihaler®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FEV1 AUC0-12
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)
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Change From Baseline in FEV1
Time Frame: Day 1
Highest value of FEV1 post dose on day 1
Day 1
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)
Time to Onset of Action (>10% Improvement in FEV1) on Day 1.
Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Time Frame: Day 1
Percentage of subjects achieving at least 12% improvement in FEV1.
Day 1
Peak Change From Baseline in Inspiratory Capacity (IC)
Time Frame: Day 1 (1 hr and 2 hr post-dose )
Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline
Day 1 (1 hr and 2 hr post-dose )
Change From Baseline in Morning Pre-dose Trough FEV1
Time Frame: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
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)
Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Peak Change From Baseline in FEV1
Time Frame: Day 7
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Day 7
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
Time Frame: Day 7
Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Day 7
Peak Change From Baseline in IC
Time Frame: Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)
Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Time Frame: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
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])
Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
Change From Baseline in Morning Post-dose Daily PEFR
Time Frame: Day 7 (30 minutes post-dose)
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])
Day 7 (30 minutes post-dose)
Change From Baseline in Mean Evening Pre-dose PEFR
Time Frame: Day 7
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)
Day 7
Change From Baseline in Mean Evening Post-dose PEFR
Time Frame: Day 7
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)
Day 7
Mean Number of Puffs of Rescue Medication
Time Frame: Day 7
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Day 7
Change From Baseline in Morning Pre-dose Trough FEV1
Time Frame: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
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)
Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Peak Change From Baseline in FEV1
Time Frame: Day 14
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Day 14
Change From Baseline for Mean Morning Pre-dose Trough IC
Time Frame: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Peak Change From Baseline in IC
Time Frame: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)
Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Change From Baseline in 12-hour Post-dose Trough FEV1
Time Frame: Day 14 (Baseline, 11.5 and 12 hours post dose)
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
Day 14 (Baseline, 11.5 and 12 hours post dose)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
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)
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]
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)
Change From Baseline in Mean Morning Post-dose Daily PEFR
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)
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]
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)
Change From Baseline in Mean Evening Pre-dose Daily PEFR
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)
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)
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)
Change From Baseline in Mean Evening Post-dose Daily PEFR
Time Frame: Through the end of the 14-Day Treatment
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)
Through the end of the 14-Day Treatment
Mean Number of Puffs of Rescue Medication (End of Treatment)
Time Frame: Day 14 (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
Day 14 (End of treatment)
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Time Frame: Day 1 through Day 14
Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Day 1 through Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Colin Reisner, MD, Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT001003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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