Long-term Safety Study for GSK573719 in Japanese | NCT01702363

NCT01702363

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
GSK573719	Experimental	125mcg	Drug: GSK573719

Name	Type	Description	Arm Group Labels	Other Names
GSK573719	Drug	GSK573719 inhalation powder inhaled orally once daily for 52 weeks.	GSK573719

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria (Visit 1):

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.
Previous use of GSK573719, the GSK573719/GW642444 combination.
Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).

Exclusion Criteria (Visit 2):

- COPD Exacerbation during run-in period: Subject must not have experienced a COPD exacerbation or a lower respiratory tract infection during run-in or at Visit 2.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Fukuoka		811-1347	Japan
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26782971	Derived	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.

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

ID	Type	URL	Comment
115361	Annotated Case Report Form	View IPD

ID	Title	Description
FG000	UMEC 125 µg QD	Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.

Baseline Characteristics Module

ID	Title	Description
BG000	UMEC 125 µg QD	Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	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.	Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.	Posted		Number		Participants		From the first dose of study medication up to 52 weeks

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	UMEC 125 µg QD	Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease