Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

March 14, 2017 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

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.

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.
118

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

  • Australia
    • New South Wales
      • Caringbah, New South Wales, Australia, 2229
        • Austrials
      • Glebe, New South Wales, Australia, 2037
        • Woolcock
      • Hornsby, New South Wales, Australia, 2077
        • Austrials
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Austrials
      • Herston, Queensland, Australia, 4006
        • Q-Pharm
    • South Australia
      • Adelaide, South Australia, Australia
        • Respiratory Research Foundation - Burnside War Memorial Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6006
        • Lung Institute of WA
  • New Zealand
    • Auckland
      • Epsom, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre
      • Greenlane East, Auckland, New Zealand, 1051
        • NZ Respiratory & Sleep Institute
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital
    • Wellington
      • Crofton Downs, Wellington, New Zealand, 6143
        • P3 Research
  • United States
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon, PC
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research

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 protocol defined inclusion/exclusion criteria may apply

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: Triple

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.
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Experimental: Inhaled PT003 (Dose 1)
PT003 MDI Dose 1
Drug: PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT003 (Dose 2)
PT003 MDI Dose 2
Drug: PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT005 (Dose 1)
PT005 MDI Dose 1
Drug: PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Experimental: Inhaled PT005 (Dose 2)
PT005 MDI Dose 2
Drug: PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Placebo Comparator: Inhaled Placebo
Placebo MDI
Drug: Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days
Active Comparator: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Tiotropium Bromide inhalation powder
Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Experimental: Inhaled PT001 (Dose 1)
PT001 MDI Dose 1
Drug: PT001 MDI
Inhaled PT001 MDI administered as two puffs BID for 7 days

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 AUC 0-12 on Day 7
Time Frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7

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 BL in FEV1 on Day 1
Time Frame: Day 1
Peak change from Baseline in FEV1 on Day 1
Day 1
Peak Change From BL in FEV1 on Day 7
Time Frame: Day 7
Peak change from Baseline (BL) in FEV1 on Day 7
Day 7
Peak Change From BL in Inspiratory Capacity on Day 1
Time Frame: Day 1
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Day 1
Peak Change From BL IC on Day 7
Time Frame: Day 7
Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Day 7
Time to Onset of Action >=10% Improvement in FEV1 on Day 1
Time Frame: Day 1
Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%
Day 1
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1
Time Frame: Day 1
Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Day 1
Change in Morning Pre-dose FEV1 on Day 7
Time Frame: Day 7
Change from Baseline in morning pre-dose FEV1 on Day 7
Day 7
12 hr Post-dose Trough FEV1 on Day 7
Time Frame: Day 7
12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Day 7
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7
Time Frame: Day 7
Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Day 7
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7
Time Frame: Day 7
Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Day 7
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7
Time Frame: Day 7
Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Day 7
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7
Time Frame: Day 7
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7
Day 7

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, M.D., 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

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, 2010

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.
November 1, 2010

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.
November 1, 2010

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 9, 2010

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 9, 2010

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 11, 2010

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.
April 26, 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.
March 14, 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.
March 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.
  • PT0031002

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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