Long-term Safety Study for GSK573719/GW642444 in Japanese (DB2115362)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376388
First received: June 9, 2011
Last updated: February 13, 2014
Last verified: December 2013
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: GSK573719/GW642444 Inhalation Powder

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
131 participants (par.) comprised the All Subjects Enrolled Population (ASEP; all par. with records in the study database). One par. in the ASEP was withdrawn due to a Good Clinical Practice violation and was thus withdrawn from the Intent-to-Treat Population (comprised of all participants who received at least one dose of study drug; n=130).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following screening and a 2-week Run-in Period, during which participants were evaluated for Baseline safety and chronic obstructive pulmonary disease (COPD) status, eligible participants entered a 52-week Treatment Period, followed by a Follow-up Period.

Reporting Groups
  Description
UMEC/VI 125/25 µg Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.

Participant Flow:   Overall Study
    UMEC/VI 125/25 µg  
STARTED     130  
COMPLETED     112  
NOT COMPLETED     18  
Adverse Event                 13  
Lack of Efficacy                 2  
Withdrawal by Subject                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
UMEC/VI 125/25 µg Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.

Baseline Measures
    UMEC/VI 125/25 µg  
Number of Participants  
[units: participants]
  130  
Age  
[units: Years]
Mean ± Standard Deviation
  70.4  ± 7.86  
Gender  
[units: Participants]
 
Female     10  
Male     120  
Race/Ethnicity, Customized  
[units: Participants]
 
Asian - Japanese Heritage     130  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period   [ Time Frame: 52 weeks ]

2.  Primary:   Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period   [ Time Frame: 52 weeks ]

3.  Secondary:   Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

4.  Secondary:   Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

5.  Secondary:   Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

6.  Secondary:   Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

7.  Secondary:   Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

8.  Secondary:   Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

9.  Secondary:   Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD   [ Time Frame: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

10.  Secondary:   Change From Baseline in Blood Pressure   [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

11.  Secondary:   Change From Baseline in Heart Rate   [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]

12.  Secondary:   Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points   [ Time Frame: Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376388     History of Changes
Other Study ID Numbers: 115362
Study First Received: June 9, 2011
Results First Received: December 19, 2013
Last Updated: February 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare