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GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00950807
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : March 4, 2014
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Tiotropium
Drug: Placebo
Drug: GSK573179

  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 were eligible completed a 4- to 7-day Run-in period prior to randomization. The treatment (trt) phase was comprised of three 14-day trt periods. Par. were randomly assigned to receive a sequence of placebo and 2 of the 9 active trts over the trt phase. Participant Flow data are presented by treatment rather than sequence.

Reporting Groups
  Description
Placebo Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
UMEC 62.5 µg QD Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
UMEC 125 µg QD Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
UMEC 250 µg QD Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
UMEC 500 µg QD Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
UMEC 1000 µg QD Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
UMEC 62.5 µg BID Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
UMEC 125 µg BID Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
UMEC 250 µg BID Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
Tiotropium 18 µg QD Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.

Participant Flow for 5 periods

Period 1:   Treatment Period 1
    Placebo   UMEC 62.5 µg QD   UMEC 125 µg QD   UMEC 250 µg QD   UMEC 500 µg QD   UMEC 1000 µg QD   UMEC 62.5 µg BID   UMEC 125 µg BID   UMEC 250 µg BID   Tiotropium 18 µg QD
STARTED   59   13   14   12   13   13   12   14   13   13 
COMPLETED   56   13   13   12   12   11   12   14   12   13 
NOT COMPLETED   3   0   1   0   1   2   0   0   1   0 
Lack of Efficacy                1                0                0                0                0                1                0                0                0                0 
Protocol Violation                1                0                0                0                0                0                0                0                0                0 
Lost to Follow-up                0                0                1                0                0                0                0                0                0                0 
Withdrawal by Subject                1                0                0                0                1                0                0                0                1                0 
Adverse Event                0                0                0                0                0                1                0                0                0                0 

Period 2:   Washout Period 1
    Placebo   UMEC 62.5 µg QD   UMEC 125 µg QD   UMEC 250 µg QD   UMEC 500 µg QD   UMEC 1000 µg QD   UMEC 62.5 µg BID   UMEC 125 µg BID   UMEC 250 µg BID   Tiotropium 18 µg QD
STARTED   56   13   13   12   12   11   12   14   12   13 
COMPLETED   51 [1]   13 [1]   13 [1]   11 [1]   11 [1]   11 [1]   10 [1]   13 [1]   11 [1]   13 [1] 
NOT COMPLETED   5   0   0   1   1   0   2   1   1   0 
Lack of Efficacy                0                0                0                0                0                0                1                0                0                0 
Withdrawal by Subject                0                0                0                0                0                0                0                0                1                0 
Protocol-defined Stopping Criteria                3                0                0                0                0                0                1                1                0                0 
Adverse Event                2                0                0                1                1                0                0                0                0                0 
[1] Participants withdrawing during washout are counted under the last treatment taken.

Period 3:   Treatment Period 2
    Placebo   UMEC 62.5 µg QD   UMEC 125 µg QD   UMEC 250 µg QD   UMEC 500 µg QD   UMEC 1000 µg QD   UMEC 62.5 µg BID   UMEC 125 µg BID   UMEC 250 µg BID   Tiotropium 18 µg QD
STARTED   53 [1]   13 [1]   10 [1]   13 [1]   13 [1]   10 [1]   10 [1]   13 [1]   11 [1]   11 [1] 
COMPLETED   51   12   10   12   13   9   9   10   11   11 
NOT COMPLETED   2   1   0   1   0   1   1   3   0   0 
Lack of Efficacy                1                0                0                0                0                0                0                0                0                0 
Withdrawal by Subject                0                0                0                0                0                0                1                2                0                0 
Protocol-defined Stopping Criteria                1                0                0                0                0                0                0                0                0                0 
Adverse Event                0                1                0                1                0                1                0                1                0                0 
[1] By crossover design, participants were assigned to a different treatment arm in each period.

Period 4:   Washout Period 2
    Placebo   UMEC 62.5 µg QD   UMEC 125 µg QD   UMEC 250 µg QD   UMEC 500 µg QD   UMEC 1000 µg QD   UMEC 62.5 µg BID   UMEC 125 µg BID   UMEC 250 µg BID   Tiotropium 18 µg QD
STARTED   51   12   10   12   13   9   9   10   11   11 
COMPLETED   47 [1]   11 [1]   10 [1]   11 [1]   12 [1]   9 [1]   8 [1]   9 [1]   11 [1]   11 [1] 
NOT COMPLETED   4   1   0   1   1   0   1   1   0   0 
Lack of Efficacy                1                0                0                0                0                0                0                0                0                0 
Protocol-defined Stopping Criteria                0                1                0                0                1                0                1                1                0                0 
Adverse Event                3                0                0                1                0                0                0                0                0                0 
[1] Participants withdrawing during washout are counted under the last treatment taken.

Period 5:   Treatment Period 3
    Placebo   UMEC 62.5 µg QD   UMEC 125 µg QD   UMEC 250 µg QD   UMEC 500 µg QD   UMEC 1000 µg QD   UMEC 62.5 µg BID   UMEC 125 µg BID   UMEC 250 µg BID   Tiotropium 18 µg QD
STARTED   46 [1]   9 [1]   10 [1]   11 [1]   12 [1]   9 [1]   12 [1]   10 [1]   9 [1]   11 [1] 
COMPLETED   45   9   10   11   12   9   11   9   9   10 
NOT COMPLETED   1   0   0   0   0   0   1   1   0   1 
Withdrawal by Subject                0                0                0                0                0                0                0                0                0                1 
Protocol-defined Stopping Criteria                1                0                0                0                0                0                0                1                0                0 
Adverse Event                0                0                0                0                0                0                1                0                0                0 
[1] By crossover design, participants were assigned to a different treatment arm in each period.



  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
All Study Treatments

The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :

UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD.


Baseline Measures
   All Study Treatments 
Overall Participants Analyzed 
[Units: Participants]
 176 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (8.12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      75  42.6% 
Male      101  57.4% 
Race/Ethnicity, Customized 
[Units: Participants]
 
African American/African Heritage   4 
White   172 


  Outcome Measures

1.  Primary:   Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period   [ Time Frame: Baseline and Day 15 of each treatment period (up to Study Day 71) ]

2.  Secondary:   Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period   [ Time Frame: Baseline and Day 14 of each treatment period (TP; up to Study Day 70) ]

3.  Secondary:   Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period   [ Time Frame: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70) ]


  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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00950807     History of Changes
Other Study ID Numbers: 113073
First Submitted: July 30, 2009
First Posted: August 3, 2009
Results First Submitted: January 16, 2014
Results First Posted: March 4, 2014
Last Update Posted: November 8, 2017