Trial Outcomes & Findings for Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis (NCT NCT01018030)
NCT ID: NCT01018030
Last Updated: 2017-05-17
Results Overview
The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).
COMPLETED
PHASE2
741 participants
Baseline and entire treatment period (up to 2 weeks)
2017-05-17
Participant Flow
Participants were randomized to a double-blind, placebo-controlled, parallel-group, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 micrograms (either once or twice daily) for the treatment of uncomplicated acute rhinosinusitis in adults and adolescent participants 12 years of age and older.
Participant milestones
| Measure |
Placebo
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
246
|
243
|
252
|
|
Overall Study
COMPLETED
|
227
|
232
|
239
|
|
Overall Study
NOT COMPLETED
|
19
|
11
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Did Not Receive Study Drug
|
1
|
3
|
0
|
Baseline Characteristics
Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Placebo
n=245 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=240 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=252 Participants
FFNS 110 mcg administered BD for 14 days
|
Total
n=737 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.1 Years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 15.64 • n=7 Participants
|
39.0 Years
STANDARD_DEVIATION 16.02 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 15.48 • n=4 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
238 participants
n=5 Participants
|
234 participants
n=7 Participants
|
244 participants
n=5 Participants
|
716 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other (Other than White and Black)
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=245 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)
|
-2.97 units on a scale
Standard Error 0.12
|
-3.36 units on a scale
Standard Error 0.13
|
-3.33 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.
Outcome measures
| Measure |
Placebo
n=243 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=239 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=247 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
First Time to Symptom Improvement
|
8 days
Interval 1.0 to 14.0
|
7 days
Interval 1.0 to 14.0
|
7 days
Interval 1.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=241 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=235 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=244 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in AM MSS
|
-3.1 units on a scale
Standard Error 0.12
|
-3.4 units on a scale
Standard Error 0.12
|
-3.3 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=236 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=242 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in PM MSS
|
-3.0 units on a scale
Standard Error 0.12
|
-3.4 units on a scale
Standard Error 0.12
|
-3.4 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=245 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score
|
-1.0 units on a scale
Standard Error 0.04
|
-1.1 units on a scale
Standard Error 0.04
|
-1.1 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=241 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=235 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=244 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score
|
-1.0 units on a scale
Standard Error 0.04
|
-1.1 units on a scale
Standard Error 0.04
|
-1.1 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=242 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score
|
-1.0 units on a scale
Standard Error 0.04
|
-1.1 units on a scale
Standard Error 0.05
|
-1.1 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=245 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score
|
-1.1 units on a scale
Standard Error 0.04
|
-1.2 units on a scale
Standard Error 0.05
|
-1.2 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=241 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=235 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=244 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score
|
-1.2 units on a scale
Standard Error 0.05
|
-1.2 units on a scale
Standard Error 0.05
|
-1.2 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=242 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score
|
-1.1 units on a scale
Standard Error 0.05
|
-1.2 units on a scale
Standard Error 0.05
|
-1.2 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=237 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=245 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score
|
-0.9 units on a scale
Standard Error 0.05
|
-1.0 units on a scale
Standard Error 0.05
|
-1.0 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=241 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=235 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=244 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score
|
-0.9 units on a scale
Standard Error 0.05
|
-1.1 units on a scale
Standard Error 0.05
|
-1.0 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and entire treatment period (up to 2 weeks)Population: ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).
Outcome measures
| Measure |
Placebo
n=242 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=236 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=242 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score
|
-0.9 units on a scale
Standard Error 0.05
|
-1.1 units on a scale
Standard Error 0.05
|
-1.0 units on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT Population
Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.
Outcome measures
| Measure |
Placebo
n=245 Participants
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=240 Participants
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=252 Participants
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)
|
7 participants
|
7 participants
|
7 participants
|
Adverse Events
Placebo
FFNS 110 mcg QD
FFNS 110 mcg BD
Serious adverse events
| Measure |
Placebo
n=245 participants at risk
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=240 participants at risk
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=252 participants at risk
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
Other adverse events
| Measure |
Placebo
n=245 participants at risk
Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
|
FFNS 110 mcg QD
n=240 participants at risk
Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
|
FFNS 110 mcg BD
n=252 participants at risk
FFNS 110 mcg administered BD for 14 days
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.4%
6/245
|
3.8%
9/240
|
4.8%
12/252
|
|
Infections and infestations
Sinusitis bacterial
|
2.4%
6/245
|
2.5%
6/240
|
1.6%
4/252
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
5/245
|
2.5%
6/240
|
1.2%
3/252
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.82%
2/245
|
0.83%
2/240
|
1.2%
3/252
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
3/245
|
0.42%
1/240
|
1.2%
3/252
|
|
Nervous system disorders
Dizziness
|
0.41%
1/245
|
0.00%
0/240
|
1.6%
4/252
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.82%
2/245
|
0.42%
1/240
|
0.79%
2/252
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/245
|
0.42%
1/240
|
1.2%
3/252
|
|
Infections and infestations
Bronchitis
|
0.82%
2/245
|
0.83%
2/240
|
0.00%
0/252
|
|
Infections and infestations
Gastroenteritis
|
0.41%
1/245
|
0.00%
0/240
|
0.79%
2/252
|
|
Infections and infestations
Nasal candidiasis
|
0.82%
2/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.82%
2/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Nasopharyngitis
|
0.41%
1/245
|
0.42%
1/240
|
0.40%
1/252
|
|
Gastrointestinal disorders
Diarrhea
|
0.82%
2/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Dry mouth
|
0.82%
2/245
|
0.00%
0/240
|
0.00%
0/252
|
|
General disorders
Fatigue
|
0.82%
2/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Infections and infestations
Acute sinusitis
|
0.41%
1/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.41%
1/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Gastrointestinal disorders
Gastritis
|
0.41%
1/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/245
|
0.42%
1/240
|
0.40%
1/252
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/245
|
0.42%
1/240
|
0.40%
1/252
|
|
Ear and labyrinth disorders
Ear pain
|
0.41%
1/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.41%
1/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Infections and infestations
Furuncle
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Influenza
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Infections and infestations
Laryngitis
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Infections and infestations
Oral herpes
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Otitis media
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Infections and infestations
Rash pustular
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Nervous system disorders
Aphonia
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Nervous system disorders
Migraine
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Oral pruritus
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Gastrointestinal disorders
Toothache
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Ear and labyrinth disorders
Otosalpingitis
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
General disorders
Asthenia
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
General disorders
Chest pain
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
General disorders
Facial pain
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
General disorders
Pyrexia
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Investigations
Alanine aminotransferase increased
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Investigations
Blood bilirubin increased
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Investigations
Glucose urine present
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Investigations
Protein urine present
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
|
Cardiac disorders
Palpitations
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Eye disorders
Eye pruritus
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Immune system disorders
Food allergy
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/245
|
0.00%
0/240
|
0.40%
1/252
|
|
Renal and urinary disorders
Haematuria
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Reproductive system and breast disorders
Breast pain
|
0.41%
1/245
|
0.00%
0/240
|
0.00%
0/252
|
|
Vascular disorders
Hypotension
|
0.00%
0/245
|
0.42%
1/240
|
0.00%
0/252
|
Additional Information
GSK Response Center
GlaxoSmithKline
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