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24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01316913
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : February 24, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: GSK573719/GW642444 125/25
Drug: GSK573719/GW642444 62.5/25
Drug: GSK573719
Drug: tiotropium bromide

  Participant Flow

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
Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to10-day run-in period and were then randomized to a 24-week treatment period. A total of 1191 par. were screened; 872 par. were randomized and 869 par. entered the treatment period.

Reporting Groups
  Description
UMEC 125 µg QD Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
UMEC/VI 62.5/25 µg QD Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
TIO18 µg QD Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.

Participant Flow:   Overall Study
    UMEC 125 µg QD   UMEC/VI 62.5/25 µg QD   UMEC/VI 125/25 µg QD   TIO18 µg QD
STARTED   222   217   215   215 
COMPLETED   165   163   166   176 
NOT COMPLETED   57   54   49   39 
Adverse Event                17                20                15                11 
Lack of Efficacy                22                12                9                13 
Protocol Violation                1                4                4                1 
Protocol-defined Stopping Criteria                7                8                11                6 
Lost to Follow-up                0                1                0                2 
Withdrawal by Subject                10                9                10                6 



  Baseline Characteristics

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
UMEC 125 µg QD Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
UMEC/VI 62.5/25 µg QD Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
TIO18 µg QD Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   UMEC 125 µg QD   UMEC/VI 62.5/25 µg QD   UMEC/VI 125/25 µg QD   TIO18 µg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 222   217   215   215   869 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (8.33)   65.0  (8.62)   63.8  (8.51)   65.2  (8.30)   64.6  (8.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      74  33.3%      77  35.5%      67  31.2%      62  28.8%      280  32.2% 
Male      148  66.7%      140  64.5%      148  68.8%      153  71.2%      589  67.8% 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage   6   8   9   8   31 
Asian - East Asian Heritage   35   34   36   34   139 
Asian - South East Asian Heritage   2   1   1   2   6 
Native Hawaiian or other Pacific Islander   0   1   0   0   1 
White - Arabic/North African Heritage   1   0   0   0   1 
White - White/Caucasian/European Heritage   169   163   160   163   655 
White - Mixed Race   0   1   0   0   1 
Mixed Race   9   9   9   8   35 


  Outcome Measures

1.  Primary:   Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169   [ Time Frame: Baseline and Day 169 ]

2.  Secondary:   Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168   [ Time Frame: Baseline and Day 168 ]

3.  Other Pre-specified:   Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01316913     History of Changes
Other Study ID Numbers: 113374
First Submitted: March 15, 2011
First Posted: March 16, 2011
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: April 4, 2017