Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)

This study has been completed.

Study NCT00633217 Information provided by GlaxoSmithKline

First Received on February 19, 2008. Last Updated on July 7, 2011 History of Changes

Results First Received: October 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease (COPD)
Interventions:	Drug: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg Drug: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg

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
HFA MDI 230/42 Mcg and Matching DISKUS Placebo	Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
DISKUS 250/50 Mcg and Matching HFA MDI Placebo	Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo

Participant Flow: Overall Study

	HFA MDI 230/42 Mcg and Matching DISKUS Placebo	DISKUS 250/50 Mcg and Matching HFA MDI Placebo
STARTED	121	126
COMPLETED	106	103
NOT COMPLETED	15	23
Adverse Event	5	9
Lack of Efficacy	0	2
Protocol Violation	3	7
Lost to Follow-up	2	2
Investigator Discretion	2	0
Withdrew Consent	3	3

Baseline Characteristics

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Reporting Groups

	Description
HFA MDI 230/42 Mcg and Matching DISKUS Placebo	Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
DISKUS 250/50 Mcg and Matching HFA MDI Placebo	Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo

Baseline Measures

	HFA MDI 230/42 Mcg and Matching DISKUS Placebo	DISKUS 250/50 Mcg and Matching HFA MDI Placebo	Total
Number of Participants [units: participants]	121	126	247
Age [units: years] Mean ( Full Range )	61.6 ( 40 to 84 )	63.4 ( 45 to 86 )	61.6 ( 40 to 86 )
Gender [units: participants]
Female	55	60	115
Male	66	66	132
Race/Ethnicity, Customized [units: participants]
African American/African Heritage	10	9	19
White - White/Caucasian/European Heritage	109	117	226
American Indian or Alaskan Native	1	0	1
White - Arabic/North African Heritage	1	0	1

Outcome Measures

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1. Primary:

Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug [ Time Frame: 2 hours after administration of blinded study drug; Baseline through Week 12 ]

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2. Secondary:

Mean Change From Baseline in AM Pre-dose FEV1 [ Time Frame: Measurement of FEV1 prior to study drug administration; Baseline through Week 12 ]

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3. Secondary:

Mean Change From Baseline in Peak Expiratory Flow [ Time Frame: Baseline through 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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00633217 History of Changes
Other Study ID Numbers:	111117
Study First Received:	February 19, 2008
Results First Received:	October 22, 2009
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration