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

A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control

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®

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: BGF MDI (PT010); Drug: GFF MDI (PT003); Drug: BFF MDI (PT009); Drug: Symbicort® Turbohaler® Inhalation Powder

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Bunkyo-ku, Japan, 113-8431
    • Research Site
  • Chuo-ku, Japan, 103-0022
    • Research Site
  • Chuo-ku, Japan, 104-0031
    • Research Site
  • Chuo-ku, Japan, 104-8560
    • Research Site
  • Date-gun, Japan, 969-1793
    • Research Site
  • Fukuoka-shi, Japan, 814-0180
    • Research Site
  • Ginowan-shi, Japan, 901-2214
    • Research Site
  • Hakata-shi, Japan, 812-0033
    • Research Site
  • Hamamatsu-shi, Japan, 430-0906
    • Research Site
  • Hamamatsu-shi, Japan, 430-8525
    • Research Site
  • Hamamatsu-shi, Japan, 434-8511
    • Research Site
  • Higashiokitama-gun, Japan, 992-0601
    • Research Site
  • Higashiosaka-shi, Japan, 577-0843
    • Research Site
  • Himeji-shi, Japan, 672-8064
    • Research Site
  • Hirakata-shi, Japan, 573-1191
    • Research Site
  • Iizuka-shi, Japan, 820-8505
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Iwata-shi, Japan, 438-8550
    • Research Site
  • Izumo-shi, Japan, 693-8501
    • Research Site
  • Izumo-shi, Japan, 693-0068
    • Research Site
  • Kagoshima-shi, Japan, 892-0847
    • Research Site
  • Kahoku-gun, Japan, 920-0293
    • Research Site
  • Kakogawa-shi, Japan, 675-0023
    • Research Site
  • Kasaoka-shi, Japan, 714-0081
    • Research Site
  • Kasuga-shi, Japan, 816-0813
    • Research Site
  • Kishiwada-shi, Japan, 596-8501
    • Research Site
  • Kiyose-shi, Japan, 204-0023
    • Research Site
  • Kobe-shi, Japan, 650-0017
    • Research Site
  • Koga-shi, Japan, 811-3195
    • Research Site
  • Kurashiki-shi, Japan, 711-0921
    • Research Site
  • Kure-shi, Japan, 737-0193
    • Research Site
  • Kure-shi, Japan, 737-8505
    • Research Site
  • Kyoto-shi, Japan, 607-8062
    • Research Site
  • Kyoto-shi, Japan, 601-8206
    • Research Site
  • Kyoto-shi, Japan, 602-8026
    • Research Site
  • Kyoto-shi, Japan, 615-8087
    • Research Site
  • Kyoto-shi, Japan, 601-1495
    • Research Site
  • Maebashi-shi, Japan, 371-0054
    • Research Site
  • Matsumoto-shi, Japan, 390-0872
    • Research Site
  • Matsusaka-shi, Japan, 515-0073
    • Research Site
  • Meguro-ku, Japan, 153-8515
    • Research Site
  • Mitaka-shi, Japan, 181-8611
    • Research Site
  • Mizunami-shi, Japan, 509-6134
    • Research Site
  • Nagaoka-shi, Japan, 940-2085
    • Research Site
  • Nagoya-shi, Japan, 466-8560
    • Research Site
  • Nagoya-shi, Japan, 454-8502
    • Research Site
  • Nagoya-shi, Japan, 457-8511
    • Research Site
  • Naha-shi, Japan, 902-0061
    • Research Site
  • Nishishirakawa-gun, Japan, 969-0213
    • Research Site
  • Obihiro-shi, Japan, 080-0013
    • Research Site
  • Ogaki-shi, Japan, 503-8502
    • Research Site
  • Oita-shi, Japan, 870-0921
    • Research Site
  • Oita-shi, Japan, 870-0951
    • Research Site
  • Okinawa-shi, Japan, 904-2143
    • Research Site
  • Ookawa-shi, Japan, 831-0016
    • Research Site
  • Osaka-shi, Japan, 543-0035
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Research Site
  • Otsu-shi, Japan, 520-0804
    • Research Site
  • Sakai-shi, Japan, 591-8555
    • Research Site
  • Sakaide-shi, Japan, 762-8550
    • Research Site
  • Sapporo-shi, Japan, 001-0901
    • Research Site
  • Sapporo-shi, Japan, 064-0915
    • Research Site
  • Sendai-shi, Japan, 980-8574
    • Research Site
  • Sendai-shi, Japan, 983-0824
    • Research Site
  • Sendai-shi, Japan, 984-8560
    • Research Site
  • Seto-shi, Japan, 489-8642
    • Research Site
  • Shinagawa-ku, Japan, 142-8666
    • Research Site
  • Shinjuku-ku, Japan, 162-0052
    • Research Site
  • Shizuoka-shi, Japan, 420-8630
    • Research Site
  • Suita-shi, Japan, 564-0013
    • Research Site
  • Tachikawa-shi, Japan, 190-0014
    • Research Site
  • Takamatsu-shi, Japan, 760-8538
    • Research Site
  • Toon-shi, Japan, 791-0281
    • Research Site
  • Toshima-ku, Japan, 171-0014
    • Research Site
  • Toyama-shi, Japan, 930-0194
    • Research Site
  • Toyama-shi, Japan, 931-8533
    • Research Site
  • Toyama-shi, Japan, 939-8282
    • Research Site
  • Yanagawa-shi, Japan, 832-0059
    • Research Site
  • Yokohama-shi, Japan, 236-0004
    • Research Site

Participation Criteria

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.
• 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.

Please refer to the study protocol for the complete inclusion criteria list.

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.

Please refer to the study protocol for the complete exclusion criteria list.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGF MDI (PT010); Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010	Drug: BGF MDI (PT010); Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010; Other Names: BGF
Experimental: GFF MDI (PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003	Drug: GFF MDI (PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003; Other Names: GFF
Experimental: BFF MDI (PT009); Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009	Drug: BFF MDI (PT009); Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009; Other Names: BFF
Active Comparator: Symbicort® Turbohaler® Inhalation Powder; Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler	Drug: Symbicort® Turbohaler® Inhalation Powder; Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler; Other Names: Symbicort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values	Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values	28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs	Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs	28 Weeks
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values	Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values	28 Weeks

Collaborators and Investigators

• Sponsor: Pearl Therapeutics, Inc.
• Investigators: Study Director: Paul M. Dorinsky, MD, Pearl Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: PT010007

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.: Yes