Trial Outcomes & Findings for Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study. (NCT NCT00570492)
NCT ID: NCT00570492
Last Updated: 2017-09-15
Results Overview
Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
474 participants
Primary outcome timeframe
Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)
Results posted on
2017-09-15
Participant Flow
After screening and a 16-week Baseline Period (Pd.), participants (par.) were randomized 1:1 to each treatment arm during the 52-week Treatment Pd. After the Treatment Pd., par. entered an 8-week Follow-up (FU) Pd. during which all par. received placebo nasal spray. Par. completing at least 12 weeks of treatment were to complete the FU Pd.
Participant milestones
| Measure |
Placebo: Baseline Period
Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
|
Placebo: Double-blind Treatment Period
Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
|
FFNS 110 mcg: Double-blind Treatment Period
Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
|
|---|---|---|---|
|
16-week Single-blind Baseline Period
STARTED
|
910
|
0
|
0
|
|
16-week Single-blind Baseline Period
COMPLETED
|
474
|
0
|
0
|
|
16-week Single-blind Baseline Period
NOT COMPLETED
|
436
|
0
|
0
|
|
52-week Double-blind Treatment Period
STARTED
|
0
|
237
|
237
|
|
52-week Double-blind Treatment Period
COMPLETED
|
0
|
187
|
186
|
|
52-week Double-blind Treatment Period
NOT COMPLETED
|
0
|
50
|
51
|
Reasons for withdrawal
| Measure |
Placebo: Baseline Period
Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
|
Placebo: Double-blind Treatment Period
Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
|
FFNS 110 mcg: Double-blind Treatment Period
Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
|
|---|---|---|---|
|
16-week Single-blind Baseline Period
Didn't Meet Inclusion/Exclusion Criteria
|
98
|
0
|
0
|
|
16-week Single-blind Baseline Period
Didn't Meet Randomization Criteria
|
263
|
0
|
0
|
|
16-week Single-blind Baseline Period
Withdrawal by Subject
|
56
|
0
|
0
|
|
16-week Single-blind Baseline Period
Protocol Violation
|
15
|
0
|
0
|
|
16-week Single-blind Baseline Period
Lost to Follow-up
|
2
|
0
|
0
|
|
16-week Single-blind Baseline Period
Adverse Event
|
1
|
0
|
0
|
|
16-week Single-blind Baseline Period
Randomized but Did'nt Receive Treatment
|
1
|
0
|
0
|
|
52-week Double-blind Treatment Period
Withdrawal by Subject
|
0
|
20
|
20
|
|
52-week Double-blind Treatment Period
Protocol Violation
|
0
|
12
|
15
|
|
52-week Double-blind Treatment Period
Lost to Follow-up
|
0
|
5
|
7
|
|
52-week Double-blind Treatment Period
Adverse Event
|
0
|
5
|
5
|
|
52-week Double-blind Treatment Period
Physician Decision
|
0
|
2
|
4
|
|
52-week Double-blind Treatment Period
Lack of Efficacy
|
0
|
3
|
0
|
|
52-week Double-blind Treatment Period
Reached Protocol-defined Stop Criteria
|
0
|
3
|
0
|
Baseline Characteristics
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
Baseline characteristics by cohort
| Measure |
Placebo
n=237 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
FFNS 110 mcg
n=237 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.61 Years
STANDARD_DEVIATION 0.969 • n=5 Participants
|
6.64 Years
STANDARD_DEVIATION 0.933 • n=7 Participants
|
6.63 Years
STANDARD_DEVIATION 0.950 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American (Amc)/African Heritage
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Amc Indian or Alaska Native (Alk N)
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
189 participants
n=5 Participants
|
199 participants
n=7 Participants
|
388 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Amc/African and Amc Indian or Alk N
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Amc/African Heritage and White
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Amc Indian or Alk N and White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian and White
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Other Pacific Islander and White
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)Population: Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period
Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.
Outcome measures
| Measure |
FFNS 110 mcg
n=217 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=218 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period
|
5.19 Centimeters per year (cm/year)
Standard Error 0.10
|
5.46 Centimeters per year (cm/year)
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)Population: Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value \<1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.
Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.
Outcome measures
| Measure |
FFNS 110 mcg
n=172 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=168 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean 24-hour Urinary Free Cortisol Excretion
End of 16-week Baseline Period, n=168, 172
|
9.242 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 5.5821
|
9.771 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 6.0479
|
|
Mean 24-hour Urinary Free Cortisol Excretion
End of 8-week Follow-up Period, n=161, 167
|
10.311 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 5.9986
|
10.615 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 6.6903
|
|
Mean 24-hour Urinary Free Cortisol Excretion
End of 52-week DB Treatment Period, n=163, 169
|
11.125 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 9.2195
|
11.340 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 9.6775
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)Population: Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.
NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (\>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (\>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (\>=1 nostril).
Outcome measures
| Measure |
FFNS 110 mcg
n=188 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=191 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Mucosal Bleeding, Improved
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Mucosal Bleeding, No Change
|
187 participants
|
190 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Mucosal Bleeding, Worsened
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Ulcers, Improved
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Polyps, Worsened
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Polyps, No Change
|
188 participants
|
190 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Ulcers, No Change
|
188 participants
|
191 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Ulcers, Worsened
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Polyps, Improved
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.
Outcome measures
| Measure |
FFNS 110 mcg
n=234 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Alk P, Baseline Period, n=231, 234
|
249.8 International Units per liter (IU/L)
Standard Deviation 67.81
|
246.8 International Units per liter (IU/L)
Standard Deviation 57.45
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Alk P, DB Treatment Period, n=184, 182
|
262.9 International Units per liter (IU/L)
Standard Deviation 71.22
|
261.9 International Units per liter (IU/L)
Standard Deviation 61.96
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Baseline Period, n=231, 234
|
15.1 International Units per liter (IU/L)
Standard Deviation 4.73
|
14.8 International Units per liter (IU/L)
Standard Deviation 4.54
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, DB Treatment Period, n=175, 179
|
27.6 International Units per liter (IU/L)
Standard Deviation 4.87
|
27.0 International Units per liter (IU/L)
Standard Deviation 5.49
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Alk P, Follow-up Period, n=175, 174
|
264.6 International Units per liter (IU/L)
Standard Deviation 67.44
|
264.2 International Units per liter (IU/L)
Standard Deviation 59.67
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, DB Treatment Period, n=184, 182
|
15.8 International Units per liter (IU/L)
Standard Deviation 5.12
|
15.9 International Units per liter (IU/L)
Standard Deviation 8.50
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Follow-up Period, n=175, 174
|
17.2 International Units per liter (IU/L)
Standard Deviation 13.15
|
16.7 International Units per liter (IU/L)
Standard Deviation 14.41
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Baseline Period, n=229, 232
|
28.1 International Units per liter (IU/L)
Standard Deviation 4.89
|
27.4 International Units per liter (IU/L)
Standard Deviation 4.89
|
|
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Follow-up Period, n=169, 174
|
28.3 International Units per liter (IU/L)
Standard Deviation 10.44
|
27.7 International Units per liter (IU/L)
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.
Outcome measures
| Measure |
FFNS 110 mcg
n=234 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Total Protein, Baseline Period, n=231, 234
|
71.9 Grams per liter (g/L)
Standard Deviation 4.30
|
72.0 Grams per liter (g/L)
Standard Deviation 3.78
|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, Baseline Period, n=231, 234
|
46.0 Grams per liter (g/L)
Standard Deviation 2.33
|
45.8 Grams per liter (g/L)
Standard Deviation 2.29
|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, DB Treatment Period, n=184, 182
|
45.9 Grams per liter (g/L)
Standard Deviation 2.25
|
45.7 Grams per liter (g/L)
Standard Deviation 2.24
|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, Follow-up Period, n=175, 175
|
45.6 Grams per liter (g/L)
Standard Deviation 2.36
|
45.8 Grams per liter (g/L)
Standard Deviation 2.31
|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Total Protein, DB Treatment Period, n=184, 182
|
71.7 Grams per liter (g/L)
Standard Deviation 3.95
|
71.7 Grams per liter (g/L)
Standard Deviation 3.76
|
|
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Total Protein, Follow-up Period, n=175, 175
|
71.5 Grams per liter (g/L)
Standard Deviation 3.83
|
71.5 Grams per liter (g/L)
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.
Outcome measures
| Measure |
FFNS 110 mcg
n=234 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, DB Treatment Period, n=184, 182
|
44.6 Micromoles (µmol)/L
Standard Deviation 8.16
|
45.0 Micromoles (µmol)/L
Standard Deviation 8.34
|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, Follow-up Period, n=175, 175
|
45.0 Micromoles (µmol)/L
Standard Deviation 7.72
|
44.5 Micromoles (µmol)/L
Standard Deviation 7.38
|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, Baseline Period, n=231, 234
|
7.2 Micromoles (µmol)/L
Standard Deviation 3.40
|
6.9 Micromoles (µmol)/L
Standard Deviation 2.43
|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, DB Treatment Period, n=184, 182
|
7.7 Micromoles (µmol)/L
Standard Deviation 3.56
|
7.2 Micromoles (µmol)/L
Standard Deviation 2.69
|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, Follow-up Period, n=175, 175
|
7.1 Micromoles (µmol)/L
Standard Deviation 3.14
|
7.0 Micromoles (µmol)/L
Standard Deviation 2.72
|
|
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, Baseline Period, n=231, 234
|
43.6 Micromoles (µmol)/L
Standard Deviation 7.96
|
43.3 Micromoles (µmol)/L
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.
Outcome measures
| Measure |
FFNS 110 mcg
n=234 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, Baseline Period, n=230, 231
|
4.86 Millimoles (mmol)/L
Standard Deviation 0.690
|
4.83 Millimoles (mmol)/L
Standard Deviation 0.683
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, Baseline Period, n=229, 232
|
2.435 Millimoles (mmol)/L
Standard Deviation 0.0993
|
2.441 Millimoles (mmol)/L
Standard Deviation 0.0786
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, Follow-up Period, n=169, 173
|
2.436 Millimoles (mmol)/L
Standard Deviation 0.0820
|
2.438 Millimoles (mmol)/L
Standard Deviation 0.0769
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, Follow-up Period, n=175, 175
|
4.75 Millimoles (mmol)/L
Standard Deviation 1.274
|
4.93 Millimoles (mmol)/L
Standard Deviation 1.219
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, DB Treatment Period, n=184, 182
|
4.78 Millimoles (mmol)/L
Standard Deviation 0.720
|
4.82 Millimoles (mmol)/L
Standard Deviation 0.782
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, Follow-up Period, n=175, 175
|
4.85 Millimoles (mmol)/L
Standard Deviation 0.700
|
4.87 Millimoles (mmol)/L
Standard Deviation 0.840
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, DB Treatment Period, n=175, 179
|
2.440 Millimoles (mmol)/L
Standard Deviation 0.0847
|
2.437 Millimoles (mmol)/L
Standard Deviation 0.0776
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Potassium, Baseline Period, n=229, 232
|
4.31 Millimoles (mmol)/L
Standard Deviation 0.437
|
4.30 Millimoles (mmol)/L
Standard Deviation 0.404
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Potassium, DB Treatment Period, n=175, 179
|
4.30 Millimoles (mmol)/L
Standard Deviation 0.345
|
4.30 Millimoles (mmol)/L
Standard Deviation 0.373
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Potassium, Follow-up Period, n=169, 173
|
4.32 Millimoles (mmol)/L
Standard Deviation 0.409
|
4.28 Millimoles (mmol)/L
Standard Deviation 0.362
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, Baseline Period, n=231, 234
|
139.3 Millimoles (mmol)/L
Standard Deviation 1.83
|
139.4 Millimoles (mmol)/L
Standard Deviation 1.90
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, DB Treatment Period, n=184, 182
|
139.2 Millimoles (mmol)/L
Standard Deviation 1.58
|
139.1 Millimoles (mmol)/L
Standard Deviation 1.65
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, Follow-up Period, n=175, 175
|
139.4 Millimoles (mmol)/L
Standard Deviation 2.19
|
139.3 Millimoles (mmol)/L
Standard Deviation 1.89
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, Baseline Period, n=231, 235
|
4.77 Millimoles (mmol)/L
Standard Deviation 1.195
|
4.99 Millimoles (mmol)/L
Standard Deviation 1.897
|
|
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, DB Treatment Period, n=184, 182
|
4.82 Millimoles (mmol)/L
Standard Deviation 1.294
|
4.82 Millimoles (mmol)/L
Standard Deviation 1.315
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.
Outcome measures
| Measure |
FFNS 110 mcg
n=231 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=228 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Basophil, Baseline Period, n=228, 231
|
0.025 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0151
|
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0176
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Lymphocyte, Follow-up Period, n=169, 173
|
2.841 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8107
|
2.871 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8784
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
WBC, Baseline Period, n=228, 231
|
7.36 Giga (10^9) cells (Gi)/L
Standard Deviation 1.818
|
7.71 Giga (10^9) cells (Gi)/L
Standard Deviation 2.077
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
WBC, Follow-up Period, n=177, 179
|
6.96 Giga (10^9) cells (Gi)/L
Standard Deviation 1.894
|
7.18 Giga (10^9) cells (Gi)/L
Standard Deviation 1.945
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Segmented Neu, Follow-up Period, n=177, 179
|
3.354 Giga (10^9) cells (Gi)/L
Standard Deviation 1.4379
|
3.572 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5623
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Basophil, DB Treatment Period, n=186, 188
|
0.027 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0184
|
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0198
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Basophil, Follow-up Period, n=177, 179
|
0.025 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0165
|
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0172
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Eosinophil, Baseline Period, n=228, 231
|
0.455 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3859
|
0.395 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3292
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Eosinophil, DB Treatment Period, n=186, 188
|
0.394 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3577
|
0.442 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3505
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Eosinophil, Follow-up Period, n=177, 179
|
0.409 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3296
|
0.419 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3337
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Lymphocyte, Baseline Period, n=228, 231
|
2.987 Giga (10^9) cells (Gi)/L
Standard Deviation 0.9158
|
3.046 Giga (10^9) cells (Gi)/L
Standard Deviation 0.9686
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Lymphocyte, DB Treatment Period, n=177, 179
|
2.820 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8424
|
2.779 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8038
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
WBC, DB Treatment Period, n=186, 188
|
6.98 Giga (10^9) cells (Gi)/L
Standard Deviation 1.896
|
7.14 Giga (10^9) cells (Gi)/L
Standard Deviation 1.899
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Monocyte, Baseline Period, n=228, 231
|
0.373 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1870
|
0.348 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1655
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Monocyte, DB Treatment Period, n=186, 188
|
0.343 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1598
|
0.320 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1393
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Monocyte, Follow-up Period, n=177, 179
|
0.326 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1592
|
0.334 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1471
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Segmented Neu, Baseline Period, n=228, 231
|
3.517 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5347
|
3.892 Giga (10^9) cells (Gi)/L
Standard Deviation 1.6722
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Segmented Neu, DB Treatment Period, n=186, 188
|
3.391 Giga (10^9) cells (Gi)/L
Standard Deviation 1.4828
|
3.572 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5407
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Platelet, Baseline Period, n=230, 230
|
314.1 Giga (10^9) cells (Gi)/L
Standard Deviation 59.46
|
313.8 Giga (10^9) cells (Gi)/L
Standard Deviation 70.19
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Platelet, DB Treatment Period, n=187, 187
|
279.5 Giga (10^9) cells (Gi)/L
Standard Deviation 49.51
|
278.6 Giga (10^9) cells (Gi)/L
Standard Deviation 55.58
|
|
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Platelet, Follow-up Period, n=175, 180
|
283.6 Giga (10^9) cells (Gi)/L
Standard Deviation 59.50
|
276.4 Giga (10^9) cells (Gi)/L
Standard Deviation 49.27
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Hemoglobin was assessed in participants at the indicated time points.
Outcome measures
| Measure |
FFNS 110 mcg
n=231 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for Hemoglobin
Follow-up Period, n=177, 180
|
130.0 g/L
Standard Deviation 7.90
|
132.1 g/L
Standard Deviation 7.43
|
|
Mean Values for Hemoglobin
Baseline Period, n=231, 231
|
128.4 g/L
Standard Deviation 8.00
|
129.5 g/L
Standard Deviation 7.87
|
|
Mean Values for Hemoglobin
DB Treatment Period, n=186, 188
|
130.8 g/L
Standard Deviation 7.77
|
131.8 g/L
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).
Outcome measures
| Measure |
FFNS 110 mcg
n=231 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for Hematocrit
Follow-up Period, n=177, 180
|
0.3844 Percentage of BV occupied by RBCs
Standard Deviation 0.02416
|
0.3906 Percentage of BV occupied by RBCs
Standard Deviation 0.02227
|
|
Mean Values for Hematocrit
Baseline Period, n=231, 231
|
0.3783 Percentage of BV occupied by RBCs
Standard Deviation 0.02480
|
0.3823 Percentage of BV occupied by RBCs
Standard Deviation 0.02296
|
|
Mean Values for Hematocrit
DB Treatment Period, n=186, 188
|
0.3873 Percentage of BV occupied by RBCs
Standard Deviation 0.02481
|
0.3904 Percentage of BV occupied by RBCs
Standard Deviation 0.02291
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
RBCs was assessed in participants at the indicated time points.
Outcome measures
| Measure |
FFNS 110 mcg
n=231 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=231 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Hematology Values for Red Blood Cells (RBCs)
Baseline Period, n=231, 231
|
4.54 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.327
|
4.59 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.312
|
|
Mean Hematology Values for Red Blood Cells (RBCs)
DB Treatment Period, n=186, 188
|
4.53 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.319
|
4.56 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.303
|
|
Mean Hematology Values for Red Blood Cells (RBCs)
Follow-up Period, n=177, 180
|
4.50 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.314
|
4.57 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.306
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for Urine pH
Baseline Period, n=233, 229
|
6.00 scores on a scale
Standard Deviation 0.536
|
6.02 scores on a scale
Standard Deviation 0.477
|
|
Mean Values for Urine pH
DB Treatment Period, n=182, 181
|
6.05 scores on a scale
Standard Deviation 0.507
|
6.02 scores on a scale
Standard Deviation 0.547
|
|
Mean Values for Urine pH
Follow-up Period, n=180, 186
|
6.05 scores on a scale
Standard Deviation 0.524
|
6.05 scores on a scale
Standard Deviation 0.538
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Mean Values for Urine Specific Gravity
DB Treatment Period, n=182, 181
|
1.0234 ratio
Standard Deviation 0.00649
|
1.0244 ratio
Standard Deviation 0.00695
|
|
Mean Values for Urine Specific Gravity
Baseline Period, n=233, 229
|
1.0234 ratio
Standard Deviation 0.00673
|
1.0240 ratio
Standard Deviation 0.00718
|
|
Mean Values for Urine Specific Gravity
Follow-up Period, n=180, 186
|
1.0242 ratio
Standard Deviation 0.00672
|
1.0237 ratio
Standard Deviation 0.00642
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Neg, Follow-up Period, n=180, 186
|
183 participants
|
179 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Pos, Follow-up Period, n=180, 186
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Neg, DB Treatment Period, n=182, 181
|
181 participants
|
182 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Pos, Baseline Period, n=233, 229
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Neg, DB Treatment Period, n=182, 181
|
176 participants
|
178 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Pos, Follow-up Period, n=180, 186
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Neg, Baseline Period, n=233, 229
|
228 participants
|
232 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Pos, DB Treatment Period, n=182, 181
|
5 participants
|
4 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Neg, Baseline Period, n=233, 229
|
229 participants
|
233 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Pos, Baseline Period, n=233, 229
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Pos, DB Treatment Period, n=182, 181
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Neg, Follow-up Period, n=180, 186
|
186 participants
|
180 participants
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Glucose-1+, Follow-up Period, n=180, 186
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Trace, Baseline Period, n=233, 229
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Tr, DB Treatment Period, n=182, 181
|
20 participants
|
20 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Glucose-Neg, Baseline Period, n=233, 229
|
229 participants
|
233 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Glucose-Neg, DB Treatment Period, n=182, 181
|
181 participants
|
181 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Glucose-Tr, DB Treatment Period, n=182, 181
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Glucose-Neg, Follow-up Period, n=180, 186
|
186 participants
|
179 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Neg, Baseline Period, n=233, 229
|
227 participants
|
231 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-1+, Baseline Period, n=233, 229
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Neg, DB Treatment Period, n=182, 181
|
176 participants
|
179 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Tr, DB Treatment Period, n=182, 181
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Neg, Follow-up Period, n=180, 186
|
184 participants
|
180 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Trace, Follow-up Period, n=180, 186
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-1+, Follow-up Period, n=180, 186
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Neg, Baseline Period, n=233, 229
|
207 participants
|
218 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Trace, Baseline Period, n=233, 229
|
18 participants
|
11 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-1+, Baseline Period, n=233, 229
|
4 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-2+, Baseline Period, n=233, 229
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Neg, DB Treatment Period, n=182, 181
|
152 participants
|
145 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-1+, DB Treatment Period, n=182, 181
|
7 participants
|
14 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-2+, DB Treatment Period, n=182, 181
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-3+, DB Treatment Period, n=182, 181
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Neg, Follow-up Period, n=180, 186
|
155 participants
|
156 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-Trace, Follow-up Period, n=180, 186
|
22 participants
|
16 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Protein-1+, Follow-up Period, n=180, 186
|
8 participants
|
6 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-2+, Follow-up Period, n=180, 186
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-3+, Follow-up Period, n=180, 186
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Trace, Baseline Period, n=233, 229
|
3 participants
|
4 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Neg, DB Treatment Period, n=182, 181
|
178 participants
|
178 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Trace, Follow-up Period, n=180, 186
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-3+, Baseline Period, n=233, 229
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Trace, Follow-up Period, n=180, 186
|
5 participants
|
5 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-1+, Follow-up Period, n=180, 186
|
8 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-3+, DB Treatment Period, n=182, 181
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Neg, Baseline Period, n=233, 229
|
226 participants
|
226 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Small, Baseline Period, n=233, 229
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Moderate, Baseline Period, n=233, 229
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-1+, Baseline Period, n=233, 229
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Trace, DB Treatment Period, n=182, 181
|
1 participants
|
4 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-1+, DB Treatment Period, n=182, 181
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-3+, DB Treatment Period, n=182, 181
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-Neg, Follow-up Period, n=180, 186
|
184 participants
|
177 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-1+, Follow-up Period, n=180, 186
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine OB-2+, Follow-up Period, n=180, 186
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Neg, Baseline Period, n=233, 229
|
219 participants
|
220 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Small, Baseline Period, n=233, 229
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Moderate, Baseline Period, n=233, 229
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Large, Baseline Period, n=233, 229
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Trace, Baseline Period, n=233, 229
|
0 participants
|
7 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-1+, Baseline Period, n=233, 229
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-2+, Baseline Period, n=233, 229
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Neg, DB Treatment Period, n=182, 181
|
163 participants
|
170 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Trace, DB Treatment Period, n=182, 181
|
4 participants
|
5 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-1+, DB Treatment Period, n=182, 181
|
6 participants
|
5 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-2+, DB Treatment Period, n=182, 181
|
7 participants
|
2 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-Neg, Follow-up Period, n=180, 186
|
167 participants
|
162 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-2+, Follow-up Period, n=180, 186
|
4 participants
|
8 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
Urine LET-3+, Follow-up Period, n=180, 186
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)Population: ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.
Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).
Outcome measures
| Measure |
FFNS 110 mcg
n=229 Participants
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
Placebo
n=233 Participants
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Clear, Follow-up Period, n=180, 186
|
137 participants
|
139 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Straw, DB Treatment Period, n=182, 181
|
7 participants
|
6 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Yellow, DB Treatment Period, n=182,181
|
155 participants
|
154 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Straw, Follow-up Period, n=180, 186
|
7 participants
|
6 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Yellow, Follow-up Period, n=180, 186
|
160 participants
|
156 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Clear, Baseline Period, n=233, 229
|
197 participants
|
188 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Cloudy, Baseline Period, n=233, 229
|
21 participants
|
23 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Turbid, Baseline Period, n=233, 229
|
11 participants
|
22 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Clear, DB Treatment Period, n=182, 181
|
139 participants
|
134 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Cloudy, DB Treatment Period, n=182, 181
|
33 participants
|
31 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Turbid, DB Treatment Period, n=182, 181
|
9 participants
|
17 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Cloudy, Follow-up Period, n=180, 186
|
35 participants
|
25 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Turbid, Follow-up Period, n=180, 186
|
14 participants
|
16 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Straw, Baseline Period, n=233, 229
|
8 participants
|
8 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-Yellow, Baseline Period, n=233, 229
|
213 participants
|
214 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-DY, Baseline Period, n=233, 229
|
8 participants
|
11 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-DY, DB Treatment Period, n=182, 181
|
19 participants
|
22 participants
|
|
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-DY, Follow-up Period, n=180, 186
|
19 participants
|
18 participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 135 other events
Deaths: 0 deaths
FFNS 110 mcg
Serious events: 2 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=237 participants at risk
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
FFNS 110 mcg
n=237 participants at risk
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/237
|
0.42%
1/237
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/237
|
0.42%
1/237
|
|
Infections and infestations
Osteomyelitis
|
0.42%
1/237
|
0.00%
0/237
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.42%
1/237
|
0.00%
0/237
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.42%
1/237
|
0.00%
0/237
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.42%
1/237
|
0.00%
0/237
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.42%
1/237
|
0.00%
0/237
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.42%
1/237
|
0.00%
0/237
|
Other adverse events
| Measure |
Placebo
n=237 participants at risk
Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
|
FFNS 110 mcg
n=237 participants at risk
Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.3%
41/237
|
15.6%
37/237
|
|
Infections and infestations
Bronchitis
|
10.1%
24/237
|
14.3%
34/237
|
|
Infections and infestations
Pharyngitis
|
7.6%
18/237
|
5.1%
12/237
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
7.2%
17/237
|
5.1%
12/237
|
|
Infections and infestations
Sinusitis
|
5.9%
14/237
|
4.6%
11/237
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.6%
11/237
|
5.5%
13/237
|
|
Infections and infestations
Influenza
|
3.4%
8/237
|
5.9%
14/237
|
|
Infections and infestations
Acute Sinusitis
|
5.5%
13/237
|
1.3%
3/237
|
|
Infections and infestations
Tonsillitis
|
3.0%
7/237
|
3.4%
8/237
|
|
Infections and infestations
Gastroenteritis
|
1.7%
4/237
|
3.8%
9/237
|
|
Infections and infestations
Gastroenteritis Viral
|
3.8%
9/237
|
1.3%
3/237
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.3%
22/237
|
6.8%
16/237
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
15/237
|
5.9%
14/237
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.8%
9/237
|
3.0%
7/237
|
|
General disorders
Pyrexia
|
5.9%
14/237
|
8.9%
21/237
|
|
Nervous system disorders
Headache
|
2.1%
5/237
|
3.4%
8/237
|
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