Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.

Study NCT00502775 Information provided by GlaxoSmithKline

First Received: July 17, 2007 Last Updated: August 20, 2009 History of Changes

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

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

Participant Flow: Overall Study

	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

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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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 ]

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