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Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®

NCT ID: NCT03262012

Last Updated: 2020-05-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-09

Study Completion Date

2018-06-15

Brief Summary

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A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®

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Detailed Description

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This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.

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)

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010

Group Type EXPERIMENTAL

BGF MDI (PT010)

Intervention Type DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010

GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003

Group Type EXPERIMENTAL

GFF MDI (PT003)

Intervention Type DRUG

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003

BFF MDI (PT009)

Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

Group Type EXPERIMENTAL

BFF MDI (PT009)

Intervention Type DRUG

Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

Symbicort® Turbohaler® Inhalation Powder

Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler

Group Type ACTIVE_COMPARATOR

Symbicort® Turbohaler® Inhalation Powder

Intervention Type DRUG

Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler

Interventions

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BGF MDI (PT010)

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010

Intervention Type DRUG

GFF MDI (PT003)

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003

Intervention Type DRUG

BFF MDI (PT009)

Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

Intervention Type DRUG

Symbicort® Turbohaler® Inhalation Powder

Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler

Intervention Type DRUG

Other Intervention Names

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BGF GFF BFF Symbicort

Eligibility Criteria

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Inclusion Criteria

* Given their signed written informed consent to participate.
* Subjects must have agreed to participate and complete the lead-in Study PT010006.
* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<80% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
* Required COPD maintenance therapy:
* All Subjects must have been on two or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening. Scheduled SABA and/or scheduled SAMA are considered inhaled maintenance therapies.

Exclusion Criteria

* Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period
* Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
* Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
* Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.
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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Paul M. Dorinsky, MD

Role: STUDY_DIRECTOR

Pearl Therapeutics, Inc.

Locations

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Research Site

Bunkyō City, , Japan

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Chūōku, , Japan

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Chūōku, , Japan

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Chūōku, , Japan

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Date-gun, , Japan

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Fukuoka, , Japan

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Ginowan-shi, , Japan

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Hakata-shi, , Japan

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Hamamatsu, , Japan

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Hamamatsu, , Japan

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Hamamatsu, , Japan

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Higashiokitama-gun, , Japan

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Higashiosaka-shi, , Japan

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Himeji-shi, , Japan

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Hirakata-shi, , Japan

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Iizuka-shi, , Japan

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Itabashi-ku, , Japan

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Iwata-shi, , Japan

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Izumo-shi, , Japan

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Izumo-shi, , Japan

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Kagoshima, , Japan

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Kahoku-gun, , Japan

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Kakogawa-shi, , Japan

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Kasaoka-shi, , Japan

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Kasuga-shi, , Japan

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Kishiwada-shi, , Japan

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Kiyose-shi, , Japan

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Kobe, , Japan

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Koga-shi, , Japan

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Kurashiki-shi, , Japan

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Kure-shi, , Japan

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Kure-shi, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Maebashi, , Japan

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Matsumoto-shi, , Japan

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Matsusaka-shi, , Japan

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Meguro-ku, , Japan

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Mitaka-shi, , Japan

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Mizunami-shi, , Japan

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Nagaoka-shi, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Naha, , Japan

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Nishishirakawa-gun, , Japan

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Obihiro-shi, , Japan

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Ogaki-shi, , Japan

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Okinawa-shi, , Japan

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Ookawa-shi, , Japan

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Osaka, , Japan

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Osakasayama-shi, , Japan

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Ōita, , Japan

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Ōita, , Japan

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Ōtsu, , Japan

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Sakaide-shi, , Japan

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Sakaishi, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Sendai, , Japan

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Seto-shi, , Japan

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Shinagawa-ku, , Japan

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Shinjuku-ku, , Japan

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Shizuoka, , Japan

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Suita-shi, , Japan

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Tachikawa-shi, , Japan

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Takamatsu, , Japan

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Toon-shi, , Japan

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Toshima-ku, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Toyama, , Japan

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Yanagawa-shi, , Japan

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Yokohama, , Japan

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Countries

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Japan

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

Other Identifiers

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PT010007

Identifier Type: -

Identifier Source: org_study_id

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