Trial Outcomes & Findings for Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS (NCT NCT00539006)
NCT ID: NCT00539006
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
377 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
Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (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
Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
Participants 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
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Pre-treatment
STARTED
|
96
|
95
|
95
|
91
|
|
Pre-treatment
COMPLETED
|
96
|
94
|
95
|
91
|
|
Pre-treatment
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
STARTED
|
96
|
94
|
95
|
91
|
|
Treatment Period 1
COMPLETED
|
96
|
94
|
93
|
90
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
2
|
1
|
|
Washout
STARTED
|
96
|
94
|
93
|
90
|
|
Washout
COMPLETED
|
76
|
84
|
77
|
81
|
|
Washout
NOT COMPLETED
|
20
|
10
|
16
|
9
|
|
Treatment Period 2
STARTED
|
76
|
84
|
77
|
81
|
|
Treatment Period 2
COMPLETED
|
75
|
83
|
77
|
81
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Post-Study
STARTED
|
75
|
83
|
77
|
81
|
|
Post-Study
COMPLETED
|
75
|
83
|
77
|
81
|
|
Post-Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (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
Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
Participants 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
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Pre-treatment
Other
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Washout
Adverse Event
|
2
|
1
|
0
|
0
|
|
Washout
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Washout
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Washout
Failed to meet continuation criteria
|
16
|
5
|
14
|
6
|
|
Washout
Other
|
1
|
1
|
2
|
3
|
|
Treatment Period 2
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS
Baseline characteristics by cohort
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=96 Participants
Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (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=95 Participants
Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=95 Participants
Participants 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=91 Participants
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
42 years
STANDARD_DEVIATION 12.48 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 14.32 • n=4 Participants
|
39.9 years
STANDARD_DEVIATION 13.33 • n=21 Participants
|
|
Gender
Female
|
62 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
262 Participants
n=21 Participants
|
|
Gender
Male
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American/African Heritage
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
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
|
|
Race/Ethnicity, Customized
White
|
88 participants
n=5 Participants
|
84 participants
n=7 Participants
|
82 participants
n=5 Participants
|
80 participants
n=4 Participants
|
334 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African-American Indian/Alaskan
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 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
|
1 participants
n=4 Participants
|
2 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 participants 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=96 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=93 Participants
Participants 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.
|
Total
n=95 Participants
All participants on both arms preference.
|
Placebo - FP/FF
n=89 Participants
Participants 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 Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Change from Baseline Treatment Period One
|
-2.7 Scores on a scale
Standard Error 0.29
|
-1.5 Scores on a scale
Standard Error 0.20
|
-2.4 Scores on a scale
Standard Error 0.24
|
-1.6 Scores on a scale
Standard Error 0.22
|
|
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Change from Baseline Treatment Period Two
|
-2.5 Scores on a scale
Standard Error 0.29
|
-1.9 Scores on a scale
Standard Error 0.24
|
-2.7 Scores on a scale
Standard Error 0.27
|
-1.7 Scores on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: End of Crossover Period (Day 22)Population: Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
Participants 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. Participant could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=96 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=95 Participants
Participants 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.
|
Total
n=191 Participants
All participants on both arms preference.
|
Placebo - FP/FF
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Preferred - Fluticasone Propionate Nasal Spray
|
21 Participants
|
17 Participants
|
38 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
No Preference
|
13 Participants
|
19 Participants
|
32 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Preferred - Fluticasone Furoate Nasal Spray
|
43 Participants
|
41 Participants
|
84 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.
Participants 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. Participant could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=77 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=77 Participants
Participants 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.
|
Total
n=154 Participants
All participants on both arms preference.
|
Placebo - FP/FF
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Preferred - Fluticasone Propionate Nasal Spray
|
15 Participants
|
17 Participants
|
32 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Preferred - Fluticasone Furoate Nasal Spray
|
43 Participants
|
46 Participants
|
89 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
No Preference
|
19 Participants
|
14 Participants
|
33 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.
Participants 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. Participant could also choose "I have no preference."
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=77 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=77 Participants
Participants 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.
|
Total
n=154 Participants
All participants on both arms preference.
|
Placebo - FP/FF
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Preferred - Fluticasone Furoate Nasal Spray
|
19 Participants
|
28 Participants
|
47 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Preferred - Fluticasone Propionate Nasal Spray
|
42 Participants
|
37 Participants
|
79 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
No Preference
|
16 Participants
|
12 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.
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=77 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=77 Participants
Participants 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.
|
Total
n=154 Participants
All participants on both arms preference.
|
Placebo - FP/FF
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Preferred - Fluticasone Furoate Nasal Spray
|
37 Participants
|
49 Participants
|
86 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Preferred - Fluticasone Propionate Nasal Spray
|
17 Participants
|
14 Participants
|
31 Participants
|
—
|
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
No Preference
|
23 Participants
|
14 Participants
|
37 Participants
|
—
|
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 participants 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.
Outcome measures
| Measure |
Fluticasone Furoate NS/Fluticasone Propionate NS
n=96 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=93 Participants
Participants 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.
|
Total
n=95 Participants
All participants on both arms preference.
|
Placebo - FP/FF
n=89 Participants
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Change from Baseline Treatment Period One
|
-2.8 Scores on a scale
Standard Error 0.30
|
-1.6 Scores on a scale
Standard Error 0.21
|
-2.6 Scores on a scale
Standard Error 0.26
|
-1.7 Scores on a scale
Standard Error 0.23
|
|
Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Change from Baseline Treatment Period Two
|
-2.6 Scores on a scale
Standard Error 0.31
|
-2.0 Scores on a scale
Standard Error 0.26
|
-2.8 Scores on a scale
Standard Error 0.28
|
-1.9 Scores on a scale
Standard Error 0.24
|
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 participants 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=96 Participants
Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (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.
|
Fluticasone Propionate NS/Fluticasone Furoate NS
n=93 Participants
Participants 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.
|
Total
n=95 Participants
All participants on both arms preference.
|
Placebo - FP/FF
n=89 Participants
Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
|
|---|---|---|---|---|
|
Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Change From Baseline Treatment Period One
|
-2.5 Scores on a scale
Standard Error 0.29
|
-1.3 Scores on a scale
Standard Error 0.21
|
-2.4 Scores on a scale
Standard Error 0.26
|
-1.6 Scores on a scale
Standard Error 0.23
|
|
Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Change From Baseline Treatment Period Two
|
-2.4 Scores on a scale
Standard Error 0.29
|
-1.9 Scores on a scale
Standard Error 0.25
|
-2.6 Scores on a scale
Standard Error 0.30
|
-1.6 Scores on a scale
Standard Error 0.22
|
Adverse Events
Fluticasone Furoate Nasal Spray
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fluticason Propionate Nasal Spray
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo - FF
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo - FP
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone Furoate Nasal Spray
n=173 participants at risk
Subjects who received Fluticasone Furoate.
|
Fluticason Propionate Nasal Spray
n=171 participants at risk
Subjects who receive Fluticasone Propionate Nasal Spray.
|
Placebo - FF
n=176 participants at risk
Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
|
Placebo - FP
n=175 participants at risk
Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.9%
5/173
|
4.7%
8/171
|
5.7%
10/176
|
5.1%
9/175
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place