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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

627

Phase

  • 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

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
Intervention / Treatment
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

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

Pearl Therapeutics, Inc.

Investigators

  • 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)

August 10, 2015

Primary Completion (Actual)

September 12, 2017

Study Completion (Actual)

September 12, 2017

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on COPD

Clinical Trials on BGF MDI 320/14.4/9.6 μg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe