A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01009463

First received: November 5, 2009

Last updated: July 10, 2014

Last verified: August 2013

History of Changes

Results First Received: May 30, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: FF/GW642444 Inhalation Powder Drug: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
FP/SAL 250/50 µg BID	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.
VI 25 µg QD	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.
FF/VI 50/25 µg QD	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.
FF/VI 100/25 µg QD	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.
FF/VI 200/25 µg QD	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.

Participant Flow for 2 periods

Period 1: 4-week, Open-label Run-In Period

	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
STARTED	2071	0	0	0	0
COMPLETED	1622	0	0	0	0
NOT COMPLETED	449	0	0	0	0
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 2: 52-week, Double-blind Treatment Period

	VI 25 µg QD	FF/VI 50/25 µg QD	FF/VI 100/25 µg QD	FF/VI 200/25 µg QD
STARTED	409	408	403	402
Completed the Treatment Period	295 ^[1]	318 ^[1]	314 ^[1]	303 ^[1]
COMPLETED	294 ^[2]	315 ^[2]	312 ^[2]	301 ^[2]
NOT COMPLETED	115	93	91	101
Adverse Event	22	25	29	31
Withdrawal by Subject	34	18	17	22
Lack of Efficacy	24	16	11	18
Protocol Violation	8	7	8	7
Met Protocol-Defined Stopping Criteria	10	14	13	10
Study Closed/Terminated	2	0	1	0
Lost to Follow-up	11	7	6	5
Physician Decision	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

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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
VI 25 µg QD	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.
FF/VI 50/25 µg QD	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.
FF/VI 100/25 µg QD	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.
FF/VI 200/25 µg QD	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	Total of all reporting groups

Baseline Measures

	VI 25 µg QD	FF/VI 50/25 µg QD	FF/VI 100/25 µg QD	FF/VI 200/25 µg QD	Total
Number of Participants [units: participants]	409	408	403	402	1622
Age [units: Years] Mean ± Standard Deviation	63.6 ± 9.43	63.6 ± 9.06	63.6 ± 9.06	63.8 ± 9.30	63.6 ± 9.21
Gender [units: Participants]
Female	170	163	172	153	658
Male	239	245	231	249	964
Race/Ethnicity, Customized [units: 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

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1. Primary:

Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean [ Time Frame: From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal ]

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2. Secondary:

Time to First Occurrence of Moderate or Severe COPD Exacerbation [ Time Frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ]

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3. Secondary:

Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean [ Time Frame: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal ]

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4. Secondary:

Change From Baseline in Trough FEV1 at Week 52 (Visit 11) [ Time Frame: Baseline to Visit 11 (Week 52)/Early Withdrawal ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12. Erratum in: Lancet Respir Med. 2013 May;1(3):186.

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01009463 History of Changes
Other Study ID Numbers:	102871
Study First Received:	November 5, 2009
Results First Received:	May 30, 2013
Last Updated:	July 10, 2014
Health Authority:	United States: Food and Drug Administration

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