Trial Outcomes & Findings for A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis (NCT NCT00682643)
NCT ID: NCT00682643
Last Updated: 2017-01-13
Results Overview
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
550 participants
Primary outcome timeframe
Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Results posted on
2017-01-13
Participant Flow
Participant milestones
| Measure |
Placebo
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
368
|
|
Overall Study
COMPLETED
|
104
|
199
|
|
Overall Study
NOT COMPLETED
|
78
|
169
|
Reasons for withdrawal
| Measure |
Placebo
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
23
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Protocol Violation
|
38
|
76
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
|
Overall Study
Physician Decision
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
53
|
|
Overall Study
Did Not Receive Study Drug
|
1
|
1
|
Baseline Characteristics
A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Placebo
n=181 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=367 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
Total
n=548 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 Years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
37.4 Years
STANDARD_DEVIATION 13.43 • n=5 Participants
|
|
Gender
Female
|
116 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Gender
Male
|
65 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
29 participants
n=5 Participants
|
50 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian Heritage
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian/South East Asian Heritage
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Asian Heritage
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
146 participants
n=5 Participants
|
303 participants
n=7 Participants
|
449 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104Population: ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.
Outcome measures
| Measure |
Placebo
n=168 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=344 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 12
|
0.60 Percentage of participants
|
0.88 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 24
|
1.24 Percentage of participants
|
1.84 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 36
|
1.93 Percentage of participants
|
2.56 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 52
|
2.68 Percentage of participants
|
3.72 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 64
|
2.68 Percentage of participants
|
3.72 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 76
|
2.68 Percentage of participants
|
3.72 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 88
|
2.68 Percentage of participants
|
4.59 Percentage of participants
|
|
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Week 104
|
2.68 Percentage of participants
|
5.09 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104Population: ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.
An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.
Outcome measures
| Measure |
Placebo
n=168 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=344 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 12
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 24
|
0.00 percentage of participants
|
0.32 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 36
|
0.00 percentage of participants
|
0.32 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 52
|
0.00 percentage of participants
|
0.71 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 64
|
0.00 percentage of participants
|
1.12 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 76
|
0.00 percentage of participants
|
1.98 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 88
|
0.84 percentage of participants
|
1.98 percentage of participants
|
|
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Week 104
|
0.84 percentage of participants
|
2.96 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=198 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
Left eye, Week 52; n=130, 251
|
0.00 scores on a scale
Standard Deviation 0.042
|
0.00 scores on a scale
Standard Deviation 0.063
|
|
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
Left eye, Week 104; n=104, 198
|
0.00 scores on a scale
Standard Deviation 0.039
|
0.00 scores on a scale
Standard Deviation 0.083
|
|
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
Right eye, Week 52; n=130, 251
|
0.00 scores on a scale
Standard Deviation 0.057
|
0.00 scores on a scale
Standard Deviation 0.061
|
|
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
Right eye, Week 104; n=104, 198
|
0.00 scores on a scale
Standard Deviation 0.042
|
-0.01 scores on a scale
Standard Deviation 0.068
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for P is defined as an increase of \>=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.7; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, -0.2; n=104, 198
|
2 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.4; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.5; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, >=0.3; n=104, 198
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, >=0.9; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, >=0.3; n=104, 198
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, <-0.3; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, -0.3; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, -0.2; n=130, 251
|
2 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, -0.1; n=130, 251
|
3 participants
|
13 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0; n=130, 251
|
121 participants
|
218 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.1; n=130, 251
|
3 participants
|
12 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.2; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.3; n=130, 251
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.4; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.5; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.6; n=130, 251
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.7; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, 0.8; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, >=0.9; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, >=0.3; n=130, 251
|
1 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, >=0.5; n=130, 251
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 52, >=1.0; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, <-0.3; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, -0.3; n=130, 251
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, -0.2; n=130, 251
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, -0.1; n=130, 251
|
0 participants
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0; n=130, 251
|
122 participants
|
218 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.1; n=130, 251
|
4 participants
|
13 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.2; n=130, 251
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.3; n=130, 251
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.4; n=130, 251
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.5; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.6; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, 0.8; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, >=0.9; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, >=0.3; n=130, 251
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, >=0.5; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 52, >=1.0; n=130, 251
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, <-0.3; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, -0.3; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, -0.1; n=104, 198
|
3 participants
|
11 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0; n=104, 198
|
94 participants
|
175 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.1; n=104, 198
|
5 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.2; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.3; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.6; n=104, 198
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.7; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, 0.8; n=104, 198
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, >=0.9; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, >=0.5; n=104, 198
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Left eye, Week 104, >=1.0; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, <-0.3; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, -0.3; n=104, 198
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, -0.2; n=104, 198
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, -0.1; n=104, 198
|
2 participants
|
14 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0; n=104, 198
|
97 participants
|
174 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.1; n=104, 198
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.2; n=104, 198
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.3; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.4; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.5; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.6; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.7; n=104, 198
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, 0.8; n=104, 198
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, >=0.5; n=104, 198
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Right eye, Week 104, >=1.0; n=104, 198
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
Right eye, Week 52; n=130, 251
|
-0.01 scores on a scale
Standard Deviation 0.229
|
0.00 scores on a scale
Standard Deviation 0.154
|
|
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
Left eye, Week 104; n=104, 198
|
0.02 scores on a scale
Standard Deviation 0.210
|
0.01 scores on a scale
Standard Deviation 0.186
|
|
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
Left eye, Week 52; n=130, 251
|
0.01 scores on a scale
Standard Deviation 0.210
|
0.00 scores on a scale
Standard Deviation 0.113
|
|
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
Right eye, Week 104; n=104, 198
|
0.02 scores on a scale
Standard Deviation 0.187
|
0.01 scores on a scale
Standard Deviation 0.186
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 52, >=0.3; n=130, 251
|
3 participants
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 52, >=0.3; n=130, 251
|
4 participants
|
4 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 52, >=0.5; n=130, 251
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 52, >=1.0; n=130, 251
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 52, >=0.5; n=130, 251
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 52, >=1.0; n=130, 251
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 104, >=0.3; n=104, 198
|
6 participants
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 104, >=0.5; n=104, 198
|
3 participants
|
4 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Left eye, Week 104, >=1.0; n=104, 198
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 104, >=0.3; n=104, 198
|
3 participants
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 104, >=0.5; n=104, 198
|
2 participants
|
4 participants
|
|
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Right eye, Week 104, >=1.0; n=104, 198
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Left eye, Week 52; n=130, 251
|
0.12 scores on a scale
Standard Deviation 0.498
|
0.06 scores on a scale
Standard Deviation 0.495
|
|
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Left eye, Week 104; n=104, 198
|
0.21 scores on a scale
Standard Deviation 0.538
|
0.10 scores on a scale
Standard Deviation 0.506
|
|
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Right eye, Week 52; n=130, 251
|
0.12 scores on a scale
Standard Deviation 0.511
|
0.06 scores on a scale
Standard Deviation 0.492
|
|
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Right eye, Week 104; n=104, 198
|
0.21 scores on a scale
Standard Deviation 0.550
|
0.09 scores on a scale
Standard Deviation 0.531
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104
Right eye, Week 104; n=104, 198
|
0.22 scores on a scale
Standard Deviation 0.452
|
0.13 scores on a scale
Standard Deviation 0.469
|
|
Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104
Left eye, Week 52; n=130, 251
|
0.14 scores on a scale
Standard Deviation 0.432
|
0.09 scores on a scale
Standard Deviation 0.402
|
|
Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104
Left eye, Week 104; n=104, 198
|
0.21 scores on a scale
Standard Deviation 0.454
|
0.13 scores on a scale
Standard Deviation 0.465
|
|
Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104
Right eye, Week 52; n=130, 251
|
0.16 scores on a scale
Standard Deviation 0.422
|
0.09 scores on a scale
Standard Deviation 0.410
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104
Left eye, Week 52; n=130, 251
|
-0.5 mm Hg
Standard Deviation 2.04
|
-0.3 mm Hg
Standard Deviation 2.26
|
|
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104
Right eye, Week 104; n=104, 198
|
-1.0 mm Hg
Standard Deviation 2.17
|
-0.7 mm Hg
Standard Deviation 2.55
|
|
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104
Left eye, Week 104; n=104, 198
|
-0.8 mm Hg
Standard Deviation 1.98
|
-0.6 mm Hg
Standard Deviation 2.41
|
|
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104
Right eye, Week 52; n=130, 251
|
-0.7 mm Hg
Standard Deviation 2.08
|
-0.4 mm Hg
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -1
|
22 participants
|
40 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 6
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP >= 15
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -1
|
22 participants
|
34 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 0
|
28 participants
|
46 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 2
|
13 participants
|
27 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP >= 15
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = <-10 to -9
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -8
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -7
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -6
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -5
|
3 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -4
|
5 participants
|
12 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -3
|
9 participants
|
19 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = -2
|
18 participants
|
40 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 0
|
36 participants
|
50 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 1
|
20 participants
|
30 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 2
|
7 participants
|
24 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 3
|
5 participants
|
19 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 4
|
4 participants
|
7 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 5
|
0 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 7
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 8
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP = 9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP >= 7
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Left eye, IOP >= 10
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = <-10 to -9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -8
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -7
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -6
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -5
|
2 participants
|
4 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -4
|
7 participants
|
14 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -3
|
9 participants
|
23 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = -2
|
25 participants
|
43 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 1
|
16 participants
|
31 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 3
|
3 participants
|
14 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 4
|
2 participants
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 5
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 6
|
0 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 7
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 8
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP = 9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP >= 7
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52
Right eye, IOP >= 10
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.
Outcome measures
| Measure |
Placebo
n=104 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=198 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -8
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -5
|
0 participants
|
7 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -4
|
6 participants
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 1
|
19 participants
|
30 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP >= 10
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = <-10 to -9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -7
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -6
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -3
|
15 participants
|
19 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -2
|
17 participants
|
31 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = -1
|
15 participants
|
32 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 0
|
21 participants
|
32 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 2
|
5 participants
|
16 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 3
|
3 participants
|
7 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 4
|
0 participants
|
6 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 5
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 6
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 7
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 8
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP = 9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP >= 7
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP >= 10
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Left eye, IOP >= 15
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = <-10 to -9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -8
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -7
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -6
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -5
|
5 participants
|
7 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -4
|
4 participants
|
15 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -3
|
10 participants
|
17 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -2
|
24 participants
|
32 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = -1
|
21 participants
|
22 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 0
|
12 participants
|
46 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 1
|
16 participants
|
23 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 2
|
6 participants
|
13 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 3
|
1 participants
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 4
|
1 participants
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 5
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 6
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 7
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 8
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP = 9
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP >= 7
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104
Right eye, IOP >= 15
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52, and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =\< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the \[decadic\] logarithm of the minimum angle of resolution \[range from +1.00 to -0.30\]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.
Outcome measures
| Measure |
Placebo
n=130 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=251 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
Left eye, Week 52; n=130, 251
|
-0.027 scores on a scale
Standard Deviation 0.0729
|
-0.013 scores on a scale
Standard Deviation 0.0778
|
|
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
Left eye, Week 104; n=104, 198
|
-0.035 scores on a scale
Standard Deviation 0.0740
|
-0.023 scores on a scale
Standard Deviation 0.0858
|
|
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
Right eye, Week 52; n=130, 251
|
-0.023 scores on a scale
Standard Deviation 0.0810
|
-0.014 scores on a scale
Standard Deviation 0.0852
|
|
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
Right eye, Week 104; n=104, 198
|
-0.025 scores on a scale
Standard Deviation 0.0992
|
-0.024 scores on a scale
Standard Deviation 0.0899
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.
The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the "cup" portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology.
Outcome measures
| Measure |
Placebo
n=104 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=198 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104
Right eye
|
0.0 percent change
Standard Deviation 7.31
|
0.0 percent change
Standard Deviation 7.39
|
|
Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104
Left eye
|
0.0 percent change
Standard Deviation 7.23
|
0.7 percent change
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104Population: ITT Population
rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).
Outcome measures
| Measure |
Placebo
n=181 Participants
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=367 Participants
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
Week 1 to 26
|
-2.12 scores on a scale
Standard Error 0.17
|
-3.19 scores on a scale
Standard Error 0.12
|
|
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
Week 27 to 52
|
-2.52 scores on a scale
Standard Error 0.21
|
-3.86 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
Week 53 to 78
|
-2.56 scores on a scale
Standard Error 0.23
|
-3.89 scores on a scale
Standard Error 0.16
|
|
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
Week 79 to 104
|
-2.59 scores on a scale
Standard Error 0.25
|
-4.10 scores on a scale
Standard Error 0.18
|
|
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
Week 1 to 104
|
-2.30 scores on a scale
Standard Error 0.18
|
-3.45 scores on a scale
Standard Error 0.13
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 97 other events
Deaths: 0 deaths
FF 110 mcg QD
Serious events: 12 serious events
Other events: 232 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=181 participants at risk
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=367 participants at risk
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/181
|
0.27%
1/367
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/181
|
0.27%
1/367
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/181
|
0.27%
1/367
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/181
|
0.27%
1/367
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/181
|
0.27%
1/367
|
|
Nervous system disorders
Convulsion
|
0.00%
0/181
|
0.27%
1/367
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/181
|
0.27%
1/367
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/181
|
0.54%
2/367
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.55%
1/181
|
0.00%
0/367
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/181
|
0.00%
0/367
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/181
|
0.27%
1/367
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.55%
1/181
|
0.00%
0/367
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/181
|
0.27%
1/367
|
|
General disorders
Chest pain
|
0.00%
0/181
|
0.27%
1/367
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.55%
1/181
|
0.00%
0/367
|
|
Infections and infestations
Pneumonia
|
0.00%
0/181
|
0.27%
1/367
|
|
Investigations
Blood pressure increased
|
0.00%
0/181
|
0.27%
1/367
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/181
|
0.27%
1/367
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/181
|
0.27%
1/367
|
|
Psychiatric disorders
Suicide attempt
|
0.55%
1/181
|
0.00%
0/367
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
1/181
|
0.00%
0/367
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/181
|
0.27%
1/367
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/181
|
0.27%
1/367
|
Other adverse events
| Measure |
Placebo
n=181 participants at risk
The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
|
FF 110 mcg QD
n=367 participants at risk
FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.8%
34/181
|
33.5%
123/367
|
|
Infections and infestations
Sinusitis
|
17.1%
31/181
|
12.8%
47/367
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
29/181
|
14.2%
52/367
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
17/181
|
12.0%
44/367
|
|
Infections and infestations
Influenza
|
8.8%
16/181
|
6.8%
25/367
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.6%
12/181
|
7.4%
27/367
|
|
Nervous system disorders
Headache
|
7.2%
13/181
|
7.9%
29/367
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
9/181
|
6.3%
23/367
|
|
Infections and infestations
Bronchitis
|
4.4%
8/181
|
8.4%
31/367
|
|
Infections and infestations
Acute sinusitis
|
3.9%
7/181
|
5.4%
20/367
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
1.7%
3/181
|
8.2%
30/367
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
3.3%
6/181
|
6.5%
24/367
|
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 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.
- Publication restrictions are in place
Restriction type: OTHER