Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

February 9, 2021 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

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.
627

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 3

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
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Research Site
      • Jasper, Alabama, United States, 35501
        • Research Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Phoenix, Arizona, United States, 85018
        • Research Site
    • California
      • Fullerton, California, United States, 92835
        • Research Site
      • Gold River, California, United States, 95670
        • Research Site
      • Poway, California, United States, 92064
        • Research Site
      • Rolling Hills Estates, California, United States, 90274
        • Research Site
      • Sacramento, California, United States, 95821
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Miami, Florida, United States, 33186
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Research Site
      • Pensacola, Florida, United States, 32503
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Research Site
      • Tampa, Florida, United States, 33603
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Dacula, Georgia, United States, 30019
        • Research Site
      • Norcross, Georgia, United States, 30071
        • Research Site
      • Rincon, Georgia, United States, 31326
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
      • Minneapolis, Minnesota, United States, 55407
        • Research Site
      • Woodbury, Minnesota, United States, 55125
        • Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Research Site
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Reno, Nevada, United States, 89503
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Hendersonville, North Carolina, United States, 28739
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Research Site
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Cincinnati, Ohio, United States, 45245
        • Research Site
      • Columbus, Ohio, United States, 43235
        • Research Site
      • Columbus, Ohio, United States, 43213
        • Research Site
      • Dayton, Ohio, United States, 45459
        • Research Site
      • Dublin, Ohio, United States, 43016
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Easley, South Carolina, United States, 29640
        • Research Site
      • Greenville, South Carolina, United States, 29615
        • Research Site
      • Indian Land, South Carolina, United States, 29707
        • Research Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
      • Seneca, South Carolina, United States, 29678
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
      • Union, South Carolina, United States, 29379
        • Research Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Research Site
    • Texas
      • Kingwood, Texas, United States, 77339
        • Research Site
      • Longview, Texas, United States, 75604
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Research Site
      • Newport News, Virginia, United States, 23606
        • Research Site
      • Richmond, Virginia, United States, 23225
        • Research Site
      • Richmond, Virginia, United States, 23230
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Research 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:

Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Exclusion Criteria:

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery

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: Parallel Assignment
  • Masking: Double

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: BGF MDI (PT010) 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
Drug: BGF MDI 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate
Other Names:
  • BGF MDI
Experimental: GFF MDI (PT003) 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
Drug: GFF MDI 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate
Other Names:
  • GFF MDI
Experimental: BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Drug: BFF MDI 320/9.6 μg
Budesonide and Formoterol Fumarate
Other Names:
  • BFF MDI

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
Percent Change From Baseline in BMD of the Lumbar Spine
Time Frame: at week 52
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
at week 52
Change From Baseline in the LOCS III (P) Score at Week 52
Time Frame: at week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
at week 52

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, Pearl Therapeutics
  • Study Director: Paul Dorinsky, MD, Pearl Therapeutics

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 (Actual)

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.
August 10, 2015

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.
September 12, 2017

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.
September 12, 2017

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).
August 27, 2015

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.
August 27, 2015

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.
September 1, 2015

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.
February 26, 2021

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.
February 9, 2021

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.
January 1, 2021

More Information

Terms related to this study

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.
  • PT010008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Conditions

Rare Diseases

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Dietary Supplements

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Locations

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