A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01009463 |
Recruitment Status :
Completed
First Posted : November 6, 2009
Results First Posted : August 19, 2013
Last Update Posted : November 9, 2017
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Pulmonary Disease, Chronic Obstructive |
Interventions |
Drug: FF/GW642444 Inhalation Powder Drug: GW642444 Inhalation Powder |
Enrollment | 1626 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | At Visit (V) 1, eligible participants (par.) entered a 4-week, open-label Run-In Period (RIP) to establish a stable Baseline. At V 2, eligible par. were randomized to a 52 week, double-blind Treatment Period. 2631 par. were screened, 2071 par. entered the RIP, and 1626 par. were randomized, out of which 1622 received at >= 1 study treatment dose. |
Arm/Group Title | FP/SAL 250/50 µg BID | VI 25 µg QD | FF/VI 50/25 µg QD | FF/VI 100/25 µg QD | FF/VI 200/25 µg QD |
---|---|---|---|---|---|
![]() |
Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study. | Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. |
Period Title: 4-week, Open-label Run-In Period | |||||
Started | 2071 | 0 | 0 | 0 | 0 |
Completed | 1622 | 0 | 0 | 0 | 0 |
Not Completed | 449 | 0 | 0 | 0 | 0 |
Reason Not Completed | |||||
Did Not Meet Continuation Criteria | 373 | 0 | 0 | 0 | 0 |
Adverse Event | 10 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 6 | 0 | 0 | 0 | 0 |
Physician Decision | 10 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 50 | 0 | 0 | 0 | 0 |
Period Title: 52-week, Double-blind Treatment Period | |||||
Started | 0 | 409 | 408 | 403 | 402 |
Completed the Treatment Period | 0 | 295 [1] | 318 [1] | 314 [1] | 303 [1] |
Completed | 0 | 294 [2] | 315 [2] | 312 [2] | 301 [2] |
Not Completed | 0 | 115 | 93 | 91 | 101 |
Reason Not Completed | |||||
Adverse Event | 0 | 22 | 25 | 29 | 31 |
Withdrawal by Subject | 0 | 34 | 18 | 17 | 22 |
Lack of Efficacy | 0 | 24 | 16 | 11 | 18 |
Protocol Violation | 0 | 8 | 7 | 8 | 7 |
Met Protocol-Defined Stopping Criteria | 0 | 10 | 14 | 13 | 10 |
Study Closed/Terminated | 0 | 2 | 0 | 1 | 0 |
Lost to Follow-up | 0 | 11 | 7 | 6 | 5 |
Physician Decision | 0 | 4 | 6 | 6 | 8 |
[1]
Par. completed the treatment period if they attended the last treatment visit (Visit 11).
[2]
Par. completed the study if they completed the treatment period and safety follow-up phone contact.
|
Baseline Characteristics
Arm/Group Title | VI 25 µg QD | FF/VI 50/25 µg QD | FF/VI 100/25 µg QD | FF/VI 200/25 µg QD | Total | |
---|---|---|---|---|---|---|
![]() |
Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 409 | 408 | 403 | 402 | 1622 | |
![]() |
[Not Specified]
|
|||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
Number Analyzed | 409 participants | 408 participants | 403 participants | 402 participants | 1622 participants | |
63.6 (9.43) | 63.6 (9.06) | 63.6 (9.06) | 63.8 (9.30) | 63.6 (9.21) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 409 participants | 408 participants | 403 participants | 402 participants | 1622 participants | |
Female |
170 41.6%
|
163 40.0%
|
172 42.7%
|
153 38.1%
|
658 40.6%
|
|
Male |
239 58.4%
|
245 60.0%
|
231 57.3%
|
249 61.9%
|
964 59.4%
|
|
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 409 participants | 408 participants | 403 participants | 402 participants | 1622 participants |
White | 331 | 334 | 332 | 324 | 1321 | |
African American/ African Heritage | 9 | 8 | 6 | 9 | 32 | |
Asian | 39 | 37 | 37 | 41 | 154 | |
American Indian or Alaska Native & White | 19 | 16 | 19 | 15 | 69 | |
Asian & White | 0 | 1 | 0 | 0 | 1 | |
American Indian or Alaska Native | 10 | 12 | 9 | 12 | 43 | |
Unknown | 1 | 0 | 0 | 1 | 2 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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: | NCT01009463 |
Other Study ID Numbers: |
102871 |
First Submitted: | November 5, 2009 |
First Posted: | November 6, 2009 |
Results First Submitted: | May 30, 2013 |
Results First Posted: | August 19, 2013 |
Last Update Posted: | November 9, 2017 |