Trial Outcomes & Findings for Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS (NCT NCT00519636)
NCT ID: NCT00519636
Last Updated: 2016-12-09
Results Overview
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
360 participants
Primary outcome timeframe
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Results posted on
2016-12-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
91
|
86
|
90
|
93
|
|
Treatment Period 1
COMPLETED
|
89
|
86
|
89
|
93
|
|
Treatment Period 1
NOT COMPLETED
|
2
|
0
|
1
|
0
|
|
Washout Period
STARTED
|
89
|
86
|
89
|
93
|
|
Washout Period
COMPLETED
|
69
|
72
|
75
|
88
|
|
Washout Period
NOT COMPLETED
|
20
|
14
|
14
|
5
|
|
Treatment Period 2
STARTED
|
69
|
72
|
75
|
88
|
|
Treatment Period 2
COMPLETED
|
69
|
71
|
74
|
86
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
1
|
2
|
|
Post Study Period
STARTED
|
69
|
71
|
74
|
86
|
|
Post Study Period
COMPLETED
|
69
|
71
|
74
|
85
|
|
Post Study Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
1
|
0
|
|
Treatment Period 1
Sponsor request due to missed visit
|
1
|
0
|
0
|
0
|
|
Washout Period
Adverse Event
|
2
|
1
|
1
|
0
|
|
Washout Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Washout Period
Protocol Violation
|
0
|
0
|
1
|
2
|
|
Washout Period
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Washout Period
Failed to meet continuation criteria
|
14
|
11
|
9
|
3
|
|
Washout Period
Out of pollen area > 48 hours
|
1
|
0
|
0
|
0
|
|
Washout Period
Participating in study at another site
|
1
|
0
|
0
|
0
|
|
Washout Period
Non-compliant
|
0
|
1
|
0
|
0
|
|
Washout Period
Per doctors request
|
0
|
1
|
0
|
0
|
|
Washout Period
Subject randomized in error
|
0
|
0
|
1
|
0
|
|
Washout Period
Prohibited medications
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Failed To Meet Continuation Criteria
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Subject randomized in error
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Per doctors request
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
Subject misrandomized
|
0
|
0
|
0
|
1
|
|
Post Study Period
Subject randomized in error
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS
Baseline characteristics by cohort
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=91 Participants
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
n=86 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=90 Participants
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
n=93 Participants
Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian: Central/South Asian Heritage
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian: Japanese/East-Southeast Asian Heritage
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=5 Participants
|
66 participants
n=7 Participants
|
63 participants
n=5 Participants
|
64 participants
n=4 Participants
|
260 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
38 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 12.55 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 11.39 • n=4 Participants
|
38.3 years
STANDARD_DEVIATION 11.91 • n=21 Participants
|
|
Gender
Female
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
|
Gender
Male
|
42 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
21 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)Population: Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=90 Participants
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
n=86 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=90 Participants
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
n=92 Participants
Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
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
Change from Baseline Treatment Period 1
|
-2.7 Scores on a scale
Standard Error 0.26
|
-1.7 Scores on a scale
Standard Error 0.22
|
-2.2 Scores on a scale
Standard Error 0.23
|
-1.5 Scores on a scale
Standard Error 0.22
|
|
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
Change from Baseline Treatment Period 2
|
-2.7 Scores on a scale
Standard Error 0.29
|
-2.1 Scores on a scale
Standard Error 0.27
|
-2.3 Scores on a scale
Standard Error 0.30
|
-1.7 Scores on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: End of Crossover Period (Day 22)Population: Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.
Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=68 Participants
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
n=74 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=142 Participants
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.
|
|---|---|---|---|---|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Perferred - Fluticasone Furoate Nasal Spray
|
41 Participants
|
41 Participants
|
82 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Perferred - Fluticasone Propionate Nasal Spray
|
18 Participants
|
20 Participants
|
38 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
No Preference
|
9 Participants
|
13 Participants
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)Population: Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour \& nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations.
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=90 Participants
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
n=86 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=89 Participants
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
n=92 Participants
Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
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
Change from Baseline- Treatment Period 1
|
-2.9 Scores on a scale
Standard Error 0.27
|
-1.6 Scores on a scale
Standard Error 0.22
|
-2.4 Scores on a scale
Standard Error 0.25
|
-1.7 Scores on a scale
Standard Error 0.23
|
|
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
Change from Baseline- Treatment Period 2
|
-2.7 Scores on a scale
Standard Error 0.29
|
-2.2 Scores on a scale
Standard Error 0.28
|
-2.4 Scores on a scale
Standard Error 0.32
|
-1.9 Scores on a scale
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)Population: Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=90 Participants
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
n=86 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=90 Participants
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
n=92 Participants
Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
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
Change from Baseline- Treatment Period 2
|
-2.7 Scores on a scale
Standard Error 0.32
|
-2.0 Scores on a scale
Standard Error 0.29
|
-2.2 Scores on a scale
Standard Error 0.32
|
-1.6 Scores on a scale
Standard Error 0.28
|
|
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
Change from Baseline- Treatment Period 1
|
-2.7 Scores on a scale
Standard Error 0.28
|
-1.7 Scores on a scale
Standard Error 0.23
|
-2.1 Scores on a scale
Standard Error 0.25
|
-1.4 Scores on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: End of Crossover Period (Day 22)Population: Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.
Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=69 Participants
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
n=73 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=142 Participants
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.
|
|---|---|---|---|---|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
Preferred - Fluticasone Furoate Nasal Spray
|
45 Participants
|
39 Participants
|
84 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
Preferred - Fluticasone Propionate Nasal Spray
|
16 Participants
|
14 Participants
|
30 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
No Preference
|
8 Participants
|
20 Participants
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: End of Crossover Period (Day 22)Population: Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.
Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=69 Participants
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
n=74 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=143 Participants
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.
|
|---|---|---|---|---|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
Preferred - Fluticasone Furoate Nasal Spray
|
28 Participants
|
30 Participants
|
58 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
Preferred - Fluticasone Propionate Nasal Spray
|
22 Participants
|
32 Participants
|
54 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
No Preference
|
19 Participants
|
12 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: End of Crossover Period (Day 22)Population: Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.
Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=69 Participants
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
n=74 Participants
Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=143 Participants
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.
|
|---|---|---|---|---|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
Preferred - Fluticasone Furoate Nasal Spray
|
38 Participants
|
44 Participants
|
82 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
Preferred - Fluticasone Propionate Nasal Spray
|
17 Participants
|
20 Participants
|
37 Participants
|
—
|
|
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
No Preference
|
14 Participants
|
10 Participants
|
24 Participants
|
—
|
Adverse Events
Fluticasone Furoate Nasal Spray
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Fluticasone Propionate Nasal Spray
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo - FF
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo -FP
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone Furoate Nasal Spray
n=166 participants at risk
Subjects who received Fluticasone Furoate.
|
Fluticasone Propionate Nasal Spray
n=159 participants at risk
Subjects who receive Fluticasone Propionate Nasal Spray.
|
Placebo - FF
n=174 participants at risk
Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
|
Placebo -FP
n=166 participants at risk
Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.2%
7/166
Since this is a cross-over study, total number of participants reflect the total number per treatment per period.
|
8.8%
14/159
Since this is a cross-over study, total number of participants reflect the total number per treatment per period.
|
6.9%
12/174
Since this is a cross-over study, total number of participants reflect the total number per treatment per period.
|
7.2%
12/166
Since this is a cross-over study, total number of participants reflect the total number per treatment per period.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER