Long-term Safety Study for GSK573719 in Japanese

NCT01702363 | Completed Phase 3 Results

• 1 other identifier: 115361
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 20

Brief Summary

The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.

  From the first dose of study medication up to 52 weeks

• Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period

  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).

  From the first dose of study medication up to 52 weeks

Secondary Outcomes (10)

• Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit

• Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD

  BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD

• Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD

  BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD

Study Arms (1)

GSK573719

EXPERIMENTAL

125mcg

Drug: GSK573719

Interventions

GSK573719 DRUG

GSK573719 inhalation powder inhaled orally once daily for 52 weeks.

GSK573719

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient.
• A signed and dated written informed consent prior to study participation.
• Japanese subjects 40 years of age or older at Visit 1.
• Male or female subjects. A female is eligible if she is of: Non-child bearing potential or Child bearing potential agrees to one of the contraceptive methods.
• Subjects with a clinical history of COPD in accordance with the definition by COPD domestic guideline.
• Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Visit 1.
• Subject with a measured post-salbutamol forced expiratory volume/forced vital capacity (FEV1/FVC) ratio of \<70% and Subjects with a measured post-salbutamol FEV1 \<80% of predicted normal values.

You may not qualify if:

• Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• A current diagnosis of asthma.
• Known respiratory disorders other than COPD.
• Subjects with historical or current evidence of clinically significant abnormalities that are uncontrolled.
• A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
• Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or magnesium stearate or a condition that contraindicates participation.
• Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
• Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
• An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1.
• Significantly abnormal finding from clinical chemistry or hematology, tests at Visit 1.
• Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day.
• Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
• A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
• Affiliation with Investigator Site.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (20)

GSK Investigational Site

Fukuoka, 811-1347, Japan

Location

GSK Investigational Site

Gunma, 371-0048, Japan

Location

GSK Investigational Site

Hokkaido, 080-0805, Japan

Location

GSK Investigational Site

Hyōgo, 670-0849, Japan

Location

GSK Investigational Site

Ibaraki, 300-0053, Japan

Location

GSK Investigational Site

Ibaraki, 302-0022, Japan

Location

GSK Investigational Site

Ishikawa, 920-8610, Japan

Location

GSK Investigational Site

Kanagawa, 239-0821, Japan

Location

GSK Investigational Site

Kyoto, 601-1495, Japan

Location

GSK Investigational Site

Miyagi, 983-0824, Japan

Location

GSK Investigational Site

Nagano, 391-0011, Japan

Location

GSK Investigational Site

Osaka, 530-0001, Japan

Location

GSK Investigational Site

Osaka, 589-0022, Japan

Location

GSK Investigational Site

Ōita, 870-0921, Japan

Location

GSK Investigational Site

Ōita, 876-0047, Japan

Location

GSK Investigational Site

Shizuoka, 436-0022, Japan

Location

GSK Investigational Site

Tokyo, 103-0027, Japan

Location

GSK Investigational Site

Tokyo, 153-8934, Japan

Location

GSK Investigational Site

Tokyo, 192-0903, Japan

Location

GSK Investigational Site

Yamanashi, 400-0031, Japan

Location

Related Publications (1)

• Yamagata E, Soutome T, Hashimoto K, Mihara K, Tohda Y. Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2016 May;32(5):967-73. doi: 10.1185/03007995.2016.1140029. Epub 2016 Feb 18.

  PMID: 26782971 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: October 8, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 9, 2017
• Results First Posted: August 8, 2014

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (20)