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 ]

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 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Measure Description	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) [units: Score on a Scale] Mean ± Standard Error	-2.9 ± 0.15	-4.1 ± 0.17	-2.9 ± 0.16

No statistical analysis provided for Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)

3. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Measure Description	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Daytime Reflective Total Nasal Symptom Score (D-rTNSS) [units: Score on a Scale] Mean ± Standard Error	-3.0 ± 0.15	-4.2 ± 0.18	-2.9 ± 0.16

No statistical analysis provided for Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)

4. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Measure Description	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) [units: Score on a Scale] Mean ± Standard Error	-2.8 ± 0.14	-4.1 ± 0.18	-2.8 ± 0.16

No statistical analysis provided for Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)

5. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Measure Description	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) [units: Score on a Scale] Mean ± Standard Error	-2.3 ± 0.13	-2.7 ± 0.14	-2.2 ± 0.13

No statistical analysis provided for Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)

6. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Measure Description	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Daytime Reflective Total Ocular Symptom Score (D-rTOSS) [units: Score on a Scale] Mean ± Standard Error	-2.5 ± 0.13	-2.9 ± 0.14	-2.4 ± 0.13

No statistical analysis provided for Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)

7. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Measure Description	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) [units: Score on a Scale] Mean ± Standard Error	-2.3 ± 0.13	-2.7 ± 0.14	-2.2 ± 0.13

No statistical analysis provided for Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)

8. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Measure Description	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) [units: Score on a Scale] Mean ± Standard Error	-2.8 ± 0.15	-4.1 ± 0.18	-2.7 ± 0.17

No statistical analysis provided for Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)

9. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Measure Description	Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
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.
No text entered.

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 Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) [units: Score on a Scale] Mean ± Standard Error	-2.2 ± 0.13	-2.7 ± 0.14	-2.2 ± 0.14

No statistical analysis provided for Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)

10. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Measure Description	Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
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.
Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.

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]	226	221	226
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) [units: Score on a Scale] Mean ± Standard Error	4.8 ± 1.27	13.0 ± 1.61	2.2 ± 1.21

No statistical analysis provided for Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)

11. Secondary:

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

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Measure Description	Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
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.
Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.

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]	226	222	226
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) [units: Score on a Scale] Mean ± Standard Error	2.3 ± 1.38	9.7 ± 1.73	0.3 ± 1.37

No statistical analysis provided for Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)

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 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Measure Description	Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.
Time Frame	Baseline, Day 15 or if Early Withdrawal Day
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.
Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ 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]	218	217	222
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) [units: Score on a Scale] Mean ± Standard Error	-1.4 ± 0.09	-2.0 ± 0.10	-1.4 ± 0.10

No statistical analysis provided for Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

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