Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

This study has been completed.

Study NCT00519636 Information provided by GlaxoSmithKline

First Received on August 21, 2007. Last Updated on November 10, 2011 History of Changes

Results First Received: November 7, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Rhinitis, Allergic, Perennial Seasonal Allergic Rhinitis
Interventions:	Drug: FPNS Drug: FFNS Drug: placebo FFNS Drug: placebo FPNS

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
Fluticasone Furoate NS/Fluticasone Propionate NS	Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
Placebo FF/FP	Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS	Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
Placebo FP/FF	Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.

Participant Flow for 4 periods

Period 1: Treatment Period 1

	Fluticasone Furoate NS/Fluticasone Propionate NS	Placebo FF/FP	Fluticasone Propionate NS/Fluticasone Furoate NS	Placebo FP/FF
STARTED	91	86	90	93
COMPLETED	89	86	89	93
NOT COMPLETED	2	0	1	0
Adverse Event	1	0	1	0
Sponsor request due to missed visit	1	0	0	0

Period 2: Washout Period

	Fluticasone Furoate NS/Fluticasone Propionate NS	Placebo FF/FP	Fluticasone Propionate NS/Fluticasone Furoate NS	Placebo FP/FF
STARTED	89	86	89	93
COMPLETED	69	72	75	88
NOT COMPLETED	20	14	14	5
Adverse Event	2	1	1	0
Lost to Follow-up	1	0	0	0
Protocol Violation	0	0	1	2
Withdrawal by Subject	1	0	1	0
Failed to meet continuation criteria	14	11	9	3
Out of pollen area > 48 hours	1	0	0	0
Participating in study at another site	1	0	0	0
Non-compliant	0	1	0	0
Per doctors request	0	1	0	0
Subject randomized in error	0	0	1	0
Prohibited medications	0	0	1	0

Period 3: Treatment Period 2

	Fluticasone Furoate NS/Fluticasone Propionate NS	Placebo FF/FP	Fluticasone Propionate NS/Fluticasone Furoate NS	Placebo FP/FF
STARTED	69	72	75	88
COMPLETED	69	71	74	86
NOT COMPLETED	0	1	1	2
Failed To Meet Continuation Criteria	0	0	0	1
Subject randomized in error	0	1	0	0
Per doctors request	0	0	1	0
Subject misrandomized	0	0	0	1

Period 4: Post Study Period

	Fluticasone Furoate NS/Fluticasone Propionate NS	Placebo FF/FP	Fluticasone Propionate NS/Fluticasone Furoate NS	Placebo FP/FF
STARTED	69	71	74	86
COMPLETED	69	71	74	85
NOT COMPLETED	0	0	0	1
Subject randomized in error	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Fluticasone Furoate NS/Fluticasone Propionate NS	Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
Placebo FF/FP	Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
Fluticasone Propionate NS/Fluticasone Furoate NS	Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
Placebo FP/FF	Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.

Baseline Measures

	Fluticasone Furoate NS/Fluticasone Propionate NS	Placebo FF/FP	Fluticasone Propionate NS/Fluticasone Furoate NS	Placebo FP/FF	Total
Number of Participants [units: participants]	91	86	90	93	360
Age [units: years] Mean ± Standard Deviation	38.8 ± 12.25	38 ± 11.54	37.2 ± 12.55	38.9 ± 11.39	38.3 ± 11.91
Gender [units: participants]
Female	49	51	60	54	214
Male	42	35	30	39	146
Race/Ethnicity, Customized [units: participants]
African American/African Heritage	15	11	23	21	70
American Indian or Alaska Native	1	0	0	0	1
Asian: Central/South Asian Heritage	1	2	1	3	7
Asian: Japanese/East-Southeast Asian Heritage	2	4	2	4	12
Native Hawaiian or other Pacific Islander	2	1	0	1	4
White	67	66	63	64	260
African American/African Heritage & Asian	1	0	0	0	1
African American/African Heritage & White	0	0	1	0	1
Unknown	2	2	0	0	4

Outcome Measures

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1. Primary:

Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos [ Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]

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2. Primary:

Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor [ Time Frame: End of Crossover Period (Day 22) ]

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3. Secondary:

Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos [ Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]

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4. Secondary:

Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos [ Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ]

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5. Secondary:

Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat [ Time Frame: End of Crossover Period (Day 22) ]

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6. Secondary:

Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use [ Time Frame: End of Crossover Period (Day 22) ]

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7. Secondary:

Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist [ Time Frame: End of Crossover Period (Day 22) ]

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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 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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00519636 History of Changes
Other Study ID Numbers:	FFU105927
Study First Received:	August 21, 2007
Results First Received:	November 7, 2008
Last Updated:	November 10, 2011
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration