A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00857766

First received: March 5, 2009

Last updated: October 18, 2012

Last verified: December 2011

History of Changes

Results First Received: December 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Pulmonary Disease, Chronic Obstructive
Interventions:	Drug: ADVAIR DISKUS™ 250/50mcg Other: Placebo

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
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Reporting Groups

	Description
FSC DISKUS 250/50 Mcg	Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Matching Placebo	Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.

Participant Flow: Overall Study

	FSC DISKUS 250/50 Mcg	Matching Placebo
STARTED	123	126
COMPLETED	92	96
NOT COMPLETED	31	30
Adverse Event	13	12
Protocol Violation	11	11
Lost to Follow-up	1	0
Investigator Discretion	2	3
Participant Withdrew Consent	4	4

Baseline Characteristics

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Reporting Groups

	Description
FSC DISKUS 250/50 Mcg	Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Matching Placebo	Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
Total	Total of all reporting groups

Baseline Measures

	FSC DISKUS 250/50 Mcg	Matching Placebo	Total
Number of Participants [units: participants]	123	126	249
Age [units: Years] Mean ± Standard Deviation	63.6 ± 8.92	63.5 ± 7.88	63.5 ± 8.40
Gender [units: Participants]
Female	55	52	107
Male	68	74	142
Race/Ethnicity, Customized [units: participants]
African American/African Heritage	7	9	16
American Indian or Alaska Native	1	2	3
Asian	1	1	2
White	114	114	228

Outcome Measures

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1. Primary:

Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]

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2. Secondary:

Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]

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3. Secondary:

Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint [ Time Frame: Baseline and the 12-Week Endpoint (up to Week 12) ]

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Serious Adverse Events

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Other Adverse Events

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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.

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
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00857766 History of Changes
Other Study ID Numbers:	112355
Study First Received:	March 5, 2009
Results First Received:	December 16, 2010
Last Updated:	October 18, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

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