A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Perennial Allergic Rhinitis
Interventions:	Drug: Fluticasone furoate nasal spray Drug: Placebo

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
Placebo	Placebo nasal spray
Fluticasone Furoate 110 Mcg	Once-daily fluticasone furoate (FF) nasal spray 110 mcg

Participant Flow: Overall Study

	Placebo	Fluticasone Furoate 110 Mcg
STARTED	155	160
COMPLETED	148	153
NOT COMPLETED	7	7
Adverse Event	1	1
Protocol Violation	3	5
Lost to Follow-up	1	0
Withdrew consent	2	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo nasal spray
Fluticasone Furoate 110 Mcg	Once-daily fluticasone furoate (FF) nasal spray 110 mcg

Baseline Measures

	Placebo	Fluticasone Furoate 110 Mcg	Total
Number of Participants [units: participants]	155	160	315
Age [units: years] Mean ± Standard Deviation	39.3 ± 15.06	38.1 ± 14.18	38.7 ± 14.61
Gender [units: participants]
Female	45	57	102
Male	110	103	213
Race/Ethnicity, Customized [units: participants]
White	140	149	289
African American/African Heritage	11	3	14
American Indian/Alaska Native	0	2	2
Asian	4	3	7
Native Hawaiian/Other Pacific Islander	0	1	1
African American/African Heritage & Asian & White	0	1	1
Asian & White	0	1	1

Outcome Measures

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1. Primary:

Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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2. Secondary:

Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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3. Secondary:

Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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4. Secondary:

Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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5. Secondary:

Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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6. Secondary:

Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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7. Secondary:

Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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8. Secondary:

Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing. [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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9. Secondary:

Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

Show Outcome Measure 9

10. Secondary:

Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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11. Secondary:

Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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12. Secondary:

Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness. [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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13. Secondary:

Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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14. Secondary:

Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

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15. Secondary:

Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S]) [ Time Frame: Baseline and Week 4 ]

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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:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00609674 History of Changes
Other Study ID Numbers:	FFU111439
Study First Received:	January 24, 2008
Results First Received:	June 22, 2009
Last Updated:	January 5, 2010
Health Authority:	United States: Food and Drug Administration