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

NCT ID: NCT02536508

Last Updated: 2021-02-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

627 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-10

Study Completion Date

2017-09-12

Brief Summary

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

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Detailed Description

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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

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-Blind

Study Groups

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BGF MDI (PT010) 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)

Group Type EXPERIMENTAL

BGF MDI 320/14.4/9.6 μg

Intervention Type DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate

GFF MDI (PT003) 14.4/9.6 μg

Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)

Group Type EXPERIMENTAL

GFF MDI 14.4/9.6 μg

Intervention Type DRUG

Glycopyrronium and Formoterol Fumarate

BFF MDI (PT009) 320/9.6 μg

Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)

Group Type EXPERIMENTAL

BFF MDI 320/9.6 μg

Intervention Type DRUG

Budesonide and Formoterol Fumarate

Interventions

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BGF MDI 320/14.4/9.6 μg

Budesonide, Glycopyrronium, and Formoterol Fumarate

Intervention Type DRUG

GFF MDI 14.4/9.6 μg

Glycopyrronium and Formoterol Fumarate

Intervention Type DRUG

BFF MDI 320/9.6 μg

Budesonide and Formoterol Fumarate

Intervention Type DRUG

Other Intervention Names

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BGF MDI GFF MDI BFF MDI

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Reisner

Role: STUDY_DIRECTOR

Pearl Therapeutics

Paul Dorinsky, MD

Role: STUDY_DIRECTOR

Pearl Therapeutics

Locations

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Research Site

Dothan, Alabama, United States

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Jasper, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Fullerton, California, United States

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Gold River, California, United States

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Poway, California, United States

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Rolling Hills Estates, California, United States

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Sacramento, California, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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Pensacola, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Dacula, Georgia, United States

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Norcross, Georgia, United States

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Rincon, Georgia, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Woodbury, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Hendersonville, North Carolina, United States

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Mooresville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dublin, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Old Point Station, South Carolina, United States

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Rock Hill, South Carolina, United States

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Seneca, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Johnson City, Tennessee, United States

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Kingwood, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Abingdon, Virginia, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Countries

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United States

References

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Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

Reference Type DERIVED
PMID: 35815359 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010008&attachmentIdentifier=d9239f6b-90fa-4a08-94a5-e39e103a3405&fileName=PT010008-01_Protocol_Version_2.0_REDACTED.pdf&versionIdentifier=

PT010008-01\_Protocol\_Version\_2.0\_REDACTED.pdf

Other Identifiers

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PT010008

Identifier Type: -

Identifier Source: org_study_id

NCT03313570

Identifier Type: -

Identifier Source: nct_alias

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