Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment
Conditions:	Allergic Rhinitis Hayfever
Intervention:	Drug: fluticasone furoate, fexofenadine

	Placebo	Fluticasone Furoate 110mcg	Fexofenadine 180 mg
STARTED	229	224	227
COMPLETED	219	209	214
NOT COMPLETED	10	15	13
Adverse Event	1	2	1
Protocol Violation	1	5	2
Withdrawal by Subject	1	1	2
Sponsor Terminated Study	1	0	1
Non-compliance with eDiary	4	1	1
Subject unable to swallow capsule	1	0	1
Logpad compliance <80%	1	0	0
Randomized in error	0	1	1
Non-compliance	0	2	2
Outside pollen area more than 48 hours	0	1	0
Declining pollen counts	0	1	1
Subject in jail	0	1	0
Subject took disallowed drug	0	0	1

	Placebo	Fluticasone Furoate 110mcg	Fexofenadine 180 mg	Total
Number of Participants [units: participants]	229	224	227	680
Age [units: Years] Mean ± Standard Deviation	34.8 ± 12.71	34.0 ± 13.55	34.3 ± 13.66	34.4 ± 13.29
Gender [units: Number of Participants]
Female	139	152	135	426
Male	90	72	92	254
Race/Ethnicity, Customized [units: Number of Participants]
White	181	189	181	551
African American	40	29	42	111
Other	8	6	4	18

Outcome Measures

1. Primary:

Mean Change From Baseline in the Nighttime Symptom Score (NSS) [ Baseline and Weeks 1-2 ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Measure Description	Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
Time Frame	Baseline and Weeks 1-2
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.
One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.

Reporting Groups

	Description
Placebo	No text entered.
Fluticasone Furoate 110mcg	No text entered.
Fexofenadine 180 mg	No text entered.

Measured Values

	Placebo	Fluticasone Furoate 110mcg	Fexofenadine 180 mg
Number of Participants Analyzed [units: participants]	228	224	226
Mean Change From Baseline in the Nighttime Symptom Score (NSS) [units: Score on a Scale] Mean ± Standard Error	-2.3 ± 0.11	-3.1 ± 0.12	-2.2 ± 0.12

Statistical Analysis 1 for Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Groups ^[1]	Fluticasone Furoate 110mcg vs. Fexofenadine 180 mg
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Net) ^[4]	-0.9
Standard Error of the mean	± 0.16
95% Confidence Interval	( -1.2 to -0.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No other strata or covariates, other than investigator, were defined.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg’s method.
[4]	Other relevant estimation information:
	Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine

Statistical Analysis 2 for Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Groups ^[1]	Placebo vs. Fluticasone Furoate 110mcg
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Net) ^[4]	-0.8
Standard Error of the mean	± 0.16
95% Confidence Interval	( -1.1 to -0.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo

Statistical Analysis 3 for Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Groups ^[1]	Placebo vs. Fexofenadine 180 mg
Method ^[2]	ANCOVA
P Value ^[3]	0.374
Mean Difference (Net) ^[4]	0.1
Standard Error of the mean	± 0.16
95% Confidence Interval	( -0.2 to 0.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo

2. Secondary:

Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 2

3. Secondary:

Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 3

4. Secondary:

Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 4

5. Secondary:

Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 5

6. Secondary:

Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 6

7. Secondary:

Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 7

8. Secondary:

Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 8

9. Secondary:

Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 9

10. Secondary:

Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 10

11. Secondary:

Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) [ Baseline and Weeks 1-2 ]

Show Outcome Measure 11

12. Secondary:

Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) [ Baseline, Day 15 or if Early Withdrawal Day ]

Show Outcome Measure 12

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 centres of a multi-centre 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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 1-866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFU109047
Study First Received:	July 17, 2007
Results First Received:	November 17, 2008
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00502775 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration