A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 Mcg Twice Daily In Symptomatic Patients With Asthma

This study has been completed.

Study NCT00452348 Information provided by GlaxoSmithKline

First Received on March 26, 2007. Last Updated on May 5, 2011 History of Changes

Results First Received: January 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID Drug: Fluticasone propionate 250 mcg BID

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 BID	Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
FP DISKUS 250 Mcg BID for 52 Weeks	Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks

Participant Flow: Overall Study

	FSC DISKUS 250/50 Mcg BID	FP DISKUS 250 Mcg BID for 52 Weeks
STARTED	310	318
COMPLETED	231	234
NOT COMPLETED	79	84
Adverse Event	6	9
Lack of Efficacy	10	9
Lost to Follow-up	14	8
Protocol Violation	22	28
Withdrawal by Subject	18	21
Other	9	9

Baseline Characteristics

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Reporting Groups

	Description
FSC DISKUS 250/50 Mcg BID	Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
FP DISKUS 250 Mcg BID for 52 Weeks	Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks

Baseline Measures

	FSC DISKUS 250/50 Mcg BID	FP DISKUS 250 Mcg BID for 52 Weeks	Total
Number of Participants [units: participants]	310	318	628
Age [units: years] Mean ± Standard Deviation	40.9 ± 15.71	39.6 ± 16.56	40.2 ± 16.15
Gender [units: participants]
Female	186	181	367
Male	124	137	261
Race/Ethnicity, Customized [units: participants]
White	254	262	516
African American	29	27	56
Asian	20	25	45
American Indian	2	0	2
Other	5	4	9

Outcome Measures

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1. Primary:

Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52 [ Time Frame: Baseline and Week 1 through Week 52 ]

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2. Secondary:

Mean Change From Baseline in AM PEF Over Weeks 1-52 [ Time Frame: Baseline and Week 1 through Week 52 ]

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3. Secondary:

Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52 [ Time Frame: Baseline and Week 1 through Week 52 ]

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4. Secondary:

Rate of Asthma Attacks Per Participant Per Year [ Time Frame: Week 1 through Week 52 ]

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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:	NCT00452348 History of Changes
Other Study ID Numbers:	ADA109057
Study First Received:	March 26, 2007
Results First Received:	January 20, 2010
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada