A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (COPD nDPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01316887
First received: March 15, 2011
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: 125/25 mcg once-daily GSK573719/GW642444
Drug: 125mcg once-daily GSK573719
Drug: Placebo once-daily

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a Run-in Period of 7 to10 days, followed by a 52-week Treatment Period. A total of 893 participants were screened; of these, 312 were screen failures, 19 were Run-in failures, 563 were randomized, and 562 received at least one dose of study drug (one participant was randomized in error but did not receive study drug).

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
UMEC 125 µg Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
UMEC/VI 125/25 µg Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.

Participant Flow:   Overall Study
    Placebo     UMEC 125 µg     UMEC/VI 125/25 µg  
STARTED     109     227     226  
COMPLETED     66     133     143  
NOT COMPLETED     43     94     83  
Adverse Event                 13                 21                 17  
Lack of Efficacy                 9                 3                 1  
Protocol Violation                 2                 6                 6  
Protocol-defined Stopping Criteria                 8                 37                 36  
Study Closed/Terminated                 2                 4                 3  
Lost to Follow-up                 1                 7                 5  
Withdrawal by Subject                 8                 16                 15  



  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.
No text entered.

Reporting Groups
  Description
Placebo Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
UMEC 125 µg Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
UMEC/VI 125/25 µg Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     UMEC 125 µg     UMEC/VI 125/25 µg     Total  
Number of Participants  
[units: participants]
  109     227     226     562  
Age  
[units: Years]
Mean ± Standard Deviation
  60.1  ± 8.28     61.7  ± 9.10     61.4  ± 9.01     61.3  ± 8.92  
Gender, Customized  
[units: Participants]
       
African American/African Heritage (HER)     3     13     14     30  
Japanese/East Asian HER/South East Asian HER     2     0     1     3  
White     104     214     211     529  
Gender  
[units: Participants]
       
Female     36     82     70     188  
Male     73     145     156     374  



  Outcome Measures
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1.  Primary:   Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)   [ Time Frame: From the start of study drug up to 52 weeks ]

2.  Secondary:   Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period   [ Time Frame: From the start of study drug up to 52 weeks ]

3.  Secondary:   Time to the First On-treatment COPD Exacerbation   [ Time Frame: From the start of study drug up to 52 weeks ]

4.  Secondary:   Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

5.  Secondary:   Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

6.  Secondary:   Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

7.  Secondary:   Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

8.  Secondary:   Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

9.  Secondary:   Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

10.  Secondary:   Change From Baseline in Hematocrit at Months 3, 6, 9, and 12   [ Time Frame: Baseline; Months 3, 6, 9, and 12 ]

11.  Secondary:   Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period   [ Time Frame: Baseline; from the start of study drug up to 52 weeks ]

12.  Secondary:   Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period   [ Time Frame: Baseline; from the start of study drug up to 52 weeks ]

13.  Secondary:   Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett’s Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia’s Formula (QTcF), and PR Interval Over the Course of the 52-week   [ Time Frame: Baseline; from the start of study drug up to 52 weeks ]

14.  Secondary:   Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period   [ Time Frame: Baseline; from the start of study drug up to 52 weeks ]

15.  Secondary:   Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline   [ Time Frame: From the start of study drug up to 52 weeks ]

16.  Secondary:   Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation   [ Time Frame: Screening; from the start of study drug up to 52 weeks ]

17.  Secondary:   Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period   [ Time Frame: Baseline; from the start of study drug up to 52 weeks ]

18.  Secondary:   Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period   [ Time Frame: From the start of study drug up to 52 weeks ]

19.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12   [ Time Frame: Baseline; Months 1, 3, 6, 9, and 12 ]


  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: NCT01316887     History of Changes
Other Study ID Numbers: 113359
Study First Received: March 15, 2011
Results First Received: December 19, 2013
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration