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
1 other identifier
interventional
416
1 country
79
Brief Summary
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®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2016
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedStudy Start
First participant enrolled
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedResults Posted
Study results publicly available
May 13, 2020
CompletedMay 13, 2020
April 1, 2020
1.8 years
February 17, 2016
March 27, 2020
May 1, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (4)
BGF MDI (PT010)
EXPERIMENTALBudesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
GFF MDI (PT003)
EXPERIMENTALGlycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
BFF MDI (PT009)
EXPERIMENTALBudesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Symbicort® Turbohaler® Inhalation Powder
ACTIVE COMPARATORBudesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Interventions
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Research Site
Bunkyō City, 113-8431, Japan
Research Site
Chūōku, 103-0022, Japan
Research Site
Chūōku, 104-0031, Japan
Research Site
Chūōku, 104-8560, Japan
Research Site
Date-gun, 969-1793, Japan
Research Site
Fukuoka, 814-0180, Japan
Research Site
Ginowan-shi, 901-2214, Japan
Research Site
Hakata-shi, 812-0033, Japan
Research Site
Hamamatsu, 430-0906, Japan
Research Site
Hamamatsu, 430-8525, Japan
Research Site
Hamamatsu, 434-8511, Japan
Research Site
Higashiokitama-gun, 992-0601, Japan
Research Site
Higashiosaka-shi, 577-0843, Japan
Research Site
Himeji-shi, 672-8064, Japan
Research Site
Hirakata-shi, 573-1191, Japan
Research Site
Iizuka-shi, 820-8505, Japan
Research Site
Itabashi-ku, 173-8610, Japan
Research Site
Iwata-shi, 438-8550, Japan
Research Site
Izumo-shi, 693-0068, Japan
Research Site
Izumo-shi, 693-8501, Japan
Research Site
Kagoshima, 892-0847, Japan
Research Site
Kahoku-gun, 920-0293, Japan
Research Site
Kakogawa-shi, 675-0023, Japan
Research Site
Kasaoka-shi, 714-0081, Japan
Research Site
Kasuga-shi, 816-0813, Japan
Research Site
Kishiwada-shi, 596-8501, Japan
Research Site
Kiyose-shi, 204-0023, Japan
Research Site
Kobe, 650-0017, Japan
Research Site
Koga-shi, 811-3195, Japan
Research Site
Kurashiki-shi, 711-0921, Japan
Research Site
Kure-shi, 737-0193, Japan
Research Site
Kure-shi, 737-8505, Japan
Research Site
Kyoto, 601-1495, Japan
Research Site
Kyoto, 601-8206, Japan
Research Site
Kyoto, 602-8026, Japan
Research Site
Kyoto, 607-8062, Japan
Research Site
Kyoto, 615-8087, Japan
Research Site
Maebashi, 371-0054, Japan
Research Site
Matsumoto-shi, 390-0872, Japan
Research Site
Matsusaka-shi, 515-0073, Japan
Research Site
Meguro-ku, 153-8515, Japan
Research Site
Mitaka-shi, 181-8611, Japan
Research Site
Mizunami-shi, 509-6134, Japan
Research Site
Nagaoka-shi, 940-2085, Japan
Research Site
Nagoya, 454-8502, Japan
Research Site
Nagoya, 457-8511, Japan
Research Site
Nagoya, 466-8560, Japan
Research Site
Naha, 902-0061, Japan
Research Site
Nishishirakawa-gun, 969-0213, Japan
Research Site
Obihiro-shi, 080-0013, Japan
Research Site
Ogaki-shi, 503-8502, Japan
Research Site
Okinawa-shi, 904-2143, Japan
Research Site
Ookawa-shi, 831-0016, Japan
Research Site
Osaka, 543-0035, Japan
Research Site
Osakasayama-shi, 589-8511, Japan
Research Site
Ōita, 870-0921, Japan
Research Site
Ōita, 870-0951, Japan
Research Site
Ōtsu, 520-0804, Japan
Research Site
Sakaide-shi, 762-8550, Japan
Research Site
Sakaishi, 591-8555, Japan
Research Site
Sapporo, 001-0901, Japan
Research Site
Sapporo, 064-0915, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Sendai, 983-0824, Japan
Research Site
Sendai, 984-8560, Japan
Research Site
Seto-shi, 489-8642, Japan
Research Site
Shinagawa-ku, 142-8666, Japan
Research Site
Shinjuku-ku, 162-0052, Japan
Research Site
Shizuoka, 420-8630, Japan
Research Site
Suita-shi, 564-0013, Japan
Research Site
Tachikawa-shi, 190-0014, Japan
Research Site
Takamatsu, 760-8538, Japan
Research Site
Toon-shi, 791-0281, Japan
Research Site
Toshima-ku, 171-0014, Japan
Research Site
Toyama, 930-0194, Japan
Research Site
Toyama, 931-8533, Japan
Research Site
Toyama, 939-8282, Japan
Research Site
Yanagawa-shi, 832-0059, Japan
Research Site
Yokohama, 236-0004, Japan
Related Publications (1)
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.
PMID: 35815359DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul M. Dorinsky, MD
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Paul M. Dorinsky, MD
Pearl Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2016
First Posted
August 25, 2017
Study Start
August 9, 2016
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
May 13, 2020
Results First Posted
May 13, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share