Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment
Condition:	Asthma
Intervention:	Drug: fluticasone propionate/salmeterol

Participant Flow

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
Sequence 1: FP, SFC, Placebo	Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 2: Placebo, SFC, FP	Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Flutucasone Propionate 100 mcg BID in the third treatment period
Sequence 3: SFC, FP, Placebo	Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
Sequence 4: SFC, Placebo, FP	Salmeterol/Fluticasone Priopionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
Sequence 5: FP, Placebo, SFC	Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
Sequence 6: Placebo, FP, SFC	Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Priopionate Combination 50/100 mcg BID in the third treatment period

Participant Flow for 3 periods

Period: First Treatment Period

	Sequence 1: FP, SFC, Placebo	Sequence 2: Placebo, SFC, FP	Sequence 3: SFC, FP, Placebo	Sequence 4: SFC, Placebo, FP	Sequence 5: FP, Placebo, SFC	Sequence 6: Placebo, FP, SFC
STARTED	4	4	4	3	4	4
COMPLETED	4	4	4	3	4	4
NOT COMPLETED	0	0	0	0	0	0

Period: Second Treatment Period

	Sequence 1: FP, SFC, Placebo	Sequence 2: Placebo, SFC, FP	Sequence 3: SFC, FP, Placebo	Sequence 4: SFC, Placebo, FP	Sequence 5: FP, Placebo, SFC	Sequence 6: Placebo, FP, SFC
STARTED	4	4	4	3	4	4
COMPLETED	4	4	4	3	3	4
NOT COMPLETED	0	0	0	0	1	0
Withdrawal by Subject	0	0	0	0	1	0

Period: Third Treatment Period

	Sequence 1: FP, SFC, Placebo	Sequence 2: Placebo, SFC, FP	Sequence 3: SFC, FP, Placebo	Sequence 4: SFC, Placebo, FP	Sequence 5: FP, Placebo, SFC	Sequence 6: Placebo, FP, SFC
STARTED	4	4	4	3	3	4
COMPLETED	4	4	4	3	3	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall Study Population	Overall Study Population: participants in all three treatment periods

Baseline Measures

	Overall Study Population
Number of Participants [units: participants]	23
Age [units: years] Mean ± Standard Deviation	36.6 ± 6.63
Gender [units: participants]
Female	9
Male	14
Race/Ethnicity, Customized [units: participants]
African American	2
Caucasion	21

Outcome Measures

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1. Primary:

Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-allergen Challenge on Day 35 [ 0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35 ]

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2. Secondary:

Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post Allergen Challenge on Day 14 [ 0-6 hours, post allergen challenge, 1 hour post treatment, Day 14 ]

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Measure Type	Secondary
Measure Title	Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post Allergen Challenge on Day 14
Measure Description	Number of peripheral blood eosinophils measured from blood draws
Time Frame	0-6 hours, post allergen challenge, 1 hour post treatment, Day 14
Safety Issue	No

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.
ITT Population

Reporting Groups

	Description
Placebo	Placebo
FP 100 Mcg BID	Fluticasone Propionate (FP) 100 mcg BID
SFC 50/100 Mcg BID	Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID

Measured Values

	Placebo	FP 100 Mcg BID	SFC 50/100 Mcg BID
Number of Participants Analyzed [units: participants]	21	23	20
Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post Allergen Challenge on Day 14 [units: Giga Units per Liter (GI/L)] Mean ( 95% Confidence Interval )	-0.023 ( -0.039 to -0.006 )	-0.022 ( -0.038 to -0.007 )	-0.013 ( -0.029 to -0.004 )

No statistical analysis provided for Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post Allergen Challenge on Day 14

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:	GSK ( Study Director )
Study ID Numbers:	HZA109912
Study First Received:	August 16, 2007
Results First Received:	July 23, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00517634 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration