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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262012
• Other study ID #: PT010007
• Status: Completed
• Phase: Phase 3
• Start date: August 9, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: April 2020
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 ß2-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.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• BGF MDI (PT010)
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
• GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
• BFF MDI (PT009)
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

Locations

Country	Name	City	State
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Date-gun
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Ginowan-shi
Japan	Research Site	Hakata-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Higashiokitama-gun
Japan	Research Site	Higashiosaka-shi
Japan	Research Site	Himeji-shi
Japan	Research Site	Hirakata-shi
Japan	Research Site	Iizuka-shi
Japan	Research Site	Itabashi-ku
Japan	Research Site	Iwata-shi
Japan	Research Site	Izumo-shi
Japan	Research Site	Izumo-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kahoku-gun
Japan	Research Site	Kakogawa-shi
Japan	Research Site	Kasaoka-shi
Japan	Research Site	Kasuga-shi
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Kiyose-shi
Japan	Research Site	Kobe-shi
Japan	Research Site	Koga-shi
Japan	Research Site	Kurashiki-shi
Japan	Research Site	Kure-shi
Japan	Research Site	Kure-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Matsumoto-shi
Japan	Research Site	Matsusaka-shi
Japan	Research Site	Meguro-ku
Japan	Research Site	Mitaka-shi
Japan	Research Site	Mizunami-shi
Japan	Research Site	Nagaoka-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Naha-shi
Japan	Research Site	Nishishirakawa-gun
Japan	Research Site	Obihiro-shi
Japan	Research Site	Ogaki-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Okinawa-shi
Japan	Research Site	Ookawa-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osakasayama-shi
Japan	Research Site	Otsu-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Sakaide-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Seto-shi
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shizuoka-shi
Japan	Research Site	Suita-shi
Japan	Research Site	Tachikawa-shi
Japan	Research Site	Takamatsu-shi
Japan	Research Site	Toon-shi
Japan	Research Site	Toshima-ku
Japan	Research Site	Toyama-shi
Japan	Research Site	Toyama-shi
Japan	Research Site	Toyama-shi
Japan	Research Site	Yanagawa-shi
Japan	Research Site	Yokohama-shi

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs	Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs	28 Weeks
Primary	Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values	Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values	28 Weeks