MedTrace Logo

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

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

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

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=39 Participants
6.64 Years
STANDARD_DEVIATION 0.933 • n=41 Participants
6.63 Years
STANDARD_DEVIATION 0.950 • n=35 Participants
Sex: Female, Male
Female
73 Participants
n=39 Participants
75 Participants
n=41 Participants
148 Participants
n=35 Participants
Sex: Female, Male
Male
164 Participants
n=39 Participants
162 Participants
n=41 Participants
326 Participants
n=35 Participants
Race/Ethnicity, Customized
African American (Amc)/African Heritage
16 participants
n=39 Participants
12 participants
n=41 Participants
28 participants
n=35 Participants
Race/Ethnicity, Customized
Amc Indian or Alaska Native (Alk N)
19 participants
n=39 Participants
18 participants
n=41 Participants
37 participants
n=35 Participants
Race/Ethnicity, Customized
Asian
7 participants
n=39 Participants
5 participants
n=41 Participants
12 participants
n=35 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 participants
n=39 Participants
0 participants
n=41 Participants
1 participants
n=35 Participants
Race/Ethnicity, Customized
White
189 participants
n=39 Participants
199 participants
n=41 Participants
388 participants
n=35 Participants
Race/Ethnicity, Customized
African Amc/African and Amc Indian or Alk N
1 participants
n=39 Participants
0 participants
n=41 Participants
1 participants
n=35 Participants
Race/Ethnicity, Customized
African Amc/African Heritage and White
1 participants
n=39 Participants
2 participants
n=41 Participants
3 participants
n=35 Participants
Race/Ethnicity, Customized
Amc Indian or Alk N and White
1 participants
n=39 Participants
0 participants
n=41 Participants
1 participants
n=35 Participants
Race/Ethnicity, Customized
Asian and White
1 participants
n=39 Participants
1 participants
n=41 Participants
2 participants
n=35 Participants
Race/Ethnicity, Customized
Native Hawaiian/ Other Pacific Islander and White
1 participants
n=39 Participants
0 participants
n=41 Participants
1 participants
n=35 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

Outcome measures
Measure
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.
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.
Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period
5.46 Centimeters per year (cm/year)
Standard Error 0.10
5.19 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

Outcome measures
Measure
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.
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.
Mean 24-hour Urinary Free Cortisol Excretion
End of 16-week Baseline Period, n=168, 172
9.771 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 6.0479
9.242 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 5.5821
Mean 24-hour Urinary Free Cortisol Excretion
End of 52-week DB Treatment Period, n=163, 169
11.340 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 9.6775
11.125 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 9.2195
Mean 24-hour Urinary Free Cortisol Excretion
End of 8-week Follow-up Period, n=161, 167
10.615 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 6.6903
10.311 Micrograms per 24 hours (mcg/24 hours)
Standard Deviation 5.9986

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

Outcome measures
Measure
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.
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.
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
1 participants
0 participants
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Polyps, No Change
190 participants
188 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
Mucosal Bleeding, Improved
1 participants
0 participants
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Mucosal Bleeding, No Change
190 participants
187 participants
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
Mucosal Bleeding, Worsened
0 participants
1 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
Ulcers, No Change
191 participants
188 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

Outcome measures
Measure
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.
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.
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
246.8 International Units per liter (IU/L)
Standard Deviation 57.45
249.8 International Units per liter (IU/L)
Standard Deviation 67.81
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
261.9 International Units per liter (IU/L)
Standard Deviation 61.96
262.9 International Units per liter (IU/L)
Standard Deviation 71.22
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
264.2 International Units per liter (IU/L)
Standard Deviation 59.67
264.6 International Units per liter (IU/L)
Standard Deviation 67.44
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
ALT, Baseline Period, n=231, 234
14.8 International Units per liter (IU/L)
Standard Deviation 4.54
15.1 International Units per liter (IU/L)
Standard Deviation 4.73
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
15.9 International Units per liter (IU/L)
Standard Deviation 8.50
15.8 International Units per liter (IU/L)
Standard Deviation 5.12
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
16.7 International Units per liter (IU/L)
Standard Deviation 14.41
17.2 International Units per liter (IU/L)
Standard Deviation 13.15
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
AST, Baseline Period, n=229, 232
27.4 International Units per liter (IU/L)
Standard Deviation 4.89
28.1 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, DB Treatment Period, n=175, 179
27.0 International Units per liter (IU/L)
Standard Deviation 5.49
27.6 International Units per liter (IU/L)
Standard Deviation 4.87
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
27.7 International Units per liter (IU/L)
Standard Deviation 8.93
28.3 International Units per liter (IU/L)
Standard Deviation 10.44

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

Outcome measures
Measure
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.
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.
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, DB Treatment Period, n=184, 182
45.7 Grams per liter (g/L)
Standard Deviation 2.24
45.9 Grams per liter (g/L)
Standard Deviation 2.25
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, Baseline Period, n=231, 234
45.8 Grams per liter (g/L)
Standard Deviation 2.29
46.0 Grams per liter (g/L)
Standard Deviation 2.33
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Albumin, Follow-up Period, n=175, 175
45.8 Grams per liter (g/L)
Standard Deviation 2.31
45.6 Grams per liter (g/L)
Standard Deviation 2.36
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Total Protein, Baseline Period, n=231, 234
72.0 Grams per liter (g/L)
Standard Deviation 3.78
71.9 Grams per liter (g/L)
Standard Deviation 4.30
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 3.76
71.7 Grams per liter (g/L)
Standard Deviation 3.95
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 3.66
71.5 Grams per liter (g/L)
Standard Deviation 3.83

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

Outcome measures
Measure
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.
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.
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, Baseline Period, n=231, 234
6.9 Micromoles (µmol)/L
Standard Deviation 2.43
7.2 Micromoles (µmol)/L
Standard Deviation 3.40
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, DB Treatment Period, n=184, 182
7.2 Micromoles (µmol)/L
Standard Deviation 2.69
7.7 Micromoles (µmol)/L
Standard Deviation 3.56
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Total Bilirubin, Follow-up Period, n=175, 175
7.0 Micromoles (µmol)/L
Standard Deviation 2.72
7.1 Micromoles (µmol)/L
Standard Deviation 3.14
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, Baseline Period, n=231, 234
43.3 Micromoles (µmol)/L
Standard Deviation 7.98
43.6 Micromoles (µmol)/L
Standard Deviation 7.96
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, DB Treatment Period, n=184, 182
45.0 Micromoles (µmol)/L
Standard Deviation 8.34
44.6 Micromoles (µmol)/L
Standard Deviation 8.16
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Creatinine, Follow-up Period, n=175, 175
44.5 Micromoles (µmol)/L
Standard Deviation 7.38
45.0 Micromoles (µmol)/L
Standard Deviation 7.72

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

Outcome measures
Measure
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.
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.
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 1.315
4.82 Millimoles (mmol)/L
Standard Deviation 1.294
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
4.93 Millimoles (mmol)/L
Standard Deviation 1.219
4.75 Millimoles (mmol)/L
Standard Deviation 1.274
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, Baseline Period, n=230, 231
4.83 Millimoles (mmol)/L
Standard Deviation 0.683
4.86 Millimoles (mmol)/L
Standard Deviation 0.690
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, DB Treatment Period, n=184, 182
4.82 Millimoles (mmol)/L
Standard Deviation 0.782
4.78 Millimoles (mmol)/L
Standard Deviation 0.720
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Glucose, Follow-up Period, n=175, 175
4.87 Millimoles (mmol)/L
Standard Deviation 0.840
4.85 Millimoles (mmol)/L
Standard Deviation 0.700
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, Baseline Period, n=229, 232
2.441 Millimoles (mmol)/L
Standard Deviation 0.0786
2.435 Millimoles (mmol)/L
Standard Deviation 0.0993
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, DB Treatment Period, n=175, 179
2.437 Millimoles (mmol)/L
Standard Deviation 0.0776
2.440 Millimoles (mmol)/L
Standard Deviation 0.0847
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Calcium, Follow-up Period, n=169, 173
2.438 Millimoles (mmol)/L
Standard Deviation 0.0769
2.436 Millimoles (mmol)/L
Standard Deviation 0.0820
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Potassium, Baseline Period, n=229, 232
4.30 Millimoles (mmol)/L
Standard Deviation 0.404
4.31 Millimoles (mmol)/L
Standard Deviation 0.437
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 0.373
4.30 Millimoles (mmol)/L
Standard Deviation 0.345
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Potassium, Follow-up Period, n=169, 173
4.28 Millimoles (mmol)/L
Standard Deviation 0.362
4.32 Millimoles (mmol)/L
Standard Deviation 0.409
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, Baseline Period, n=231, 234
139.4 Millimoles (mmol)/L
Standard Deviation 1.90
139.3 Millimoles (mmol)/L
Standard Deviation 1.83
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, DB Treatment Period, n=184, 182
139.1 Millimoles (mmol)/L
Standard Deviation 1.65
139.2 Millimoles (mmol)/L
Standard Deviation 1.58
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Sodium, Follow-up Period, n=175, 175
139.3 Millimoles (mmol)/L
Standard Deviation 1.89
139.4 Millimoles (mmol)/L
Standard Deviation 2.19
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, Baseline Period, n=231, 235
4.99 Millimoles (mmol)/L
Standard Deviation 1.897
4.77 Millimoles (mmol)/L
Standard Deviation 1.195

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

Outcome measures
Measure
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.
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.
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
2.779 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8038
2.820 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8424
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Eosinophil, Baseline Period, n=228, 231
0.395 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3292
0.455 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3859
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
0.419 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3337
0.409 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3296
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
0.320 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1393
0.343 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1598
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
2.871 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8784
2.841 Giga (10^9) cells (Gi)/L
Standard Deviation 0.8107
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
WBC, Baseline Period, n=228, 231
7.71 Giga (10^9) cells (Gi)/L
Standard Deviation 2.077
7.36 Giga (10^9) cells (Gi)/L
Standard Deviation 1.818
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Platelet, Baseline Period, n=230, 230
313.8 Giga (10^9) cells (Gi)/L
Standard Deviation 70.19
314.1 Giga (10^9) cells (Gi)/L
Standard Deviation 59.46
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Basophil, Baseline Period, n=228, 231
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0176
0.025 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0151
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
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0198
0.027 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0184
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
0.026 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0172
0.025 Giga (10^9) cells (Gi)/L
Standard Deviation 0.0165
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
0.442 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3505
0.394 Giga (10^9) cells (Gi)/L
Standard Deviation 0.3577
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Lymphocyte, Baseline Period, n=228, 231
3.046 Giga (10^9) cells (Gi)/L
Standard Deviation 0.9686
2.987 Giga (10^9) cells (Gi)/L
Standard Deviation 0.9158
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
7.14 Giga (10^9) cells (Gi)/L
Standard Deviation 1.899
6.98 Giga (10^9) cells (Gi)/L
Standard Deviation 1.896
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
7.18 Giga (10^9) cells (Gi)/L
Standard Deviation 1.945
6.96 Giga (10^9) cells (Gi)/L
Standard Deviation 1.894
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Monocyte, Baseline Period, n=228, 231
0.348 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1655
0.373 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1870
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
0.334 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1471
0.326 Giga (10^9) cells (Gi)/L
Standard Deviation 0.1592
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
3.892 Giga (10^9) cells (Gi)/L
Standard Deviation 1.6722
3.517 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5347
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
3.572 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5407
3.391 Giga (10^9) cells (Gi)/L
Standard Deviation 1.4828
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
3.572 Giga (10^9) cells (Gi)/L
Standard Deviation 1.5623
3.354 Giga (10^9) cells (Gi)/L
Standard Deviation 1.4379
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
278.6 Giga (10^9) cells (Gi)/L
Standard Deviation 55.58
279.5 Giga (10^9) cells (Gi)/L
Standard Deviation 49.51
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
276.4 Giga (10^9) cells (Gi)/L
Standard Deviation 49.27
283.6 Giga (10^9) cells (Gi)/L
Standard Deviation 59.50

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

Outcome measures
Measure
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.
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.
Mean Values for Hemoglobin
Baseline Period, n=231, 231
129.5 g/L
Standard Deviation 7.87
128.4 g/L
Standard Deviation 8.00
Mean Values for Hemoglobin
DB Treatment Period, n=186, 188
131.8 g/L
Standard Deviation 7.32
130.8 g/L
Standard Deviation 7.77
Mean Values for Hemoglobin
Follow-up Period, n=177, 180
132.1 g/L
Standard Deviation 7.43
130.0 g/L
Standard Deviation 7.90

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

Outcome measures
Measure
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.
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.
Mean Values for Hematocrit
DB Treatment Period, n=186, 188
0.3904 Percentage of BV occupied by RBCs
Standard Deviation 0.02291
0.3873 Percentage of BV occupied by RBCs
Standard Deviation 0.02481
Mean Values for Hematocrit
Follow-up Period, n=177, 180
0.3906 Percentage of BV occupied by RBCs
Standard Deviation 0.02227
0.3844 Percentage of BV occupied by RBCs
Standard Deviation 0.02416
Mean Values for Hematocrit
Baseline Period, n=231, 231
0.3823 Percentage of BV occupied by RBCs
Standard Deviation 0.02296
0.3783 Percentage of BV occupied by RBCs
Standard Deviation 0.02480

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

Outcome measures
Measure
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.
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.
Mean Hematology Values for Red Blood Cells (RBCs)
Baseline Period, n=231, 231
4.59 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.312
4.54 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.327
Mean Hematology Values for Red Blood Cells (RBCs)
DB Treatment Period, n=186, 188
4.56 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.303
4.53 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.319
Mean Hematology Values for Red Blood Cells (RBCs)
Follow-up Period, n=177, 180
4.57 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.306
4.50 Trillion (10^12) cells (Ti)/L
Standard Deviation 0.314

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

Outcome measures
Measure
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.
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.
Mean Values for Urine pH
Baseline Period, n=233, 229
6.02 scores on a scale
Standard Deviation 0.477
6.00 scores on a scale
Standard Deviation 0.536
Mean Values for Urine pH
DB Treatment Period, n=182, 181
6.02 scores on a scale
Standard Deviation 0.547
6.05 scores on a scale
Standard Deviation 0.507
Mean Values for Urine pH
Follow-up Period, n=180, 186
6.05 scores on a scale
Standard Deviation 0.538
6.05 scores on a scale
Standard Deviation 0.524

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

Outcome measures
Measure
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.
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.
Mean Values for Urine Specific Gravity
Baseline Period, n=233, 229
1.0240 ratio
Standard Deviation 0.00718
1.0234 ratio
Standard Deviation 0.00673
Mean Values for Urine Specific Gravity
DB Treatment Period, n=182, 181
1.0244 ratio
Standard Deviation 0.00695
1.0234 ratio
Standard Deviation 0.00649
Mean Values for Urine Specific Gravity
Follow-up Period, n=180, 186
1.0237 ratio
Standard Deviation 0.00642
1.0242 ratio
Standard Deviation 0.00672

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

Outcome measures
Measure
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.
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.
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
UB-Neg, Baseline Period, n=233, 229
233 participants
229 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-Neg, DB Treatment Period, n=182, 181
182 participants
181 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
180 participants
186 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
232 participants
228 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
178 participants
176 participants
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Pos, DB Treatment Period, n=182, 181
4 participants
5 participants
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Neg, Follow-up Period, n=180, 186
179 participants
183 participants
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
Urine Nitrite-Pos, Follow-up Period, n=180, 186
1 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.

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

Outcome measures
Measure
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.
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.
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
Urine Ketones-Trace, Baseline Period, n=233, 229
0 participants
1 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
2 participants
1 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
179 participants
176 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
3 participants
5 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
180 participants
184 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
218 participants
207 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
11 participants
18 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
2 participants
4 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
2 participants
0 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
145 participants
152 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 Protein-1+, DB Treatment Period, n=182, 181
14 participants
7 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-Trace, Follow-up Period, n=180, 186
16 participants
22 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-Neg, Baseline Period, n=233, 229
233 participants
229 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
1 participants
0 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
179 participants
186 participants
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
1 participants
0 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
231 participants
227 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
0 participants
1 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
0 participants
1 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
1 participants
0 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
6 participants
8 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
156 participants
155 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
1 participants
0 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

Outcome measures
Measure
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.
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.
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-3+, DB Treatment Period, n=182, 181
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
4 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+, DB Treatment Period, n=182, 181
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-Neg, Follow-up Period, n=180, 186
177 participants
184 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 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
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-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 OB-Trace, Baseline Period, n=233, 229
4 participants
3 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
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-1+, Follow-up Period, n=180, 186
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 OB-2+, Follow-up Period, n=180, 186
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 LET-Neg, Baseline Period, n=233, 229
220 participants
219 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
1 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-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 LET-Large, 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 LET-Trace, Baseline Period, n=233, 229
7 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-1+, Baseline Period, n=233, 229
3 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-2+, Baseline Period, n=233, 229
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 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-Neg, DB Treatment Period, n=182, 181
170 participants
163 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
5 participants
4 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
5 participants
6 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
2 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-3+, DB Treatment Period, n=182, 181
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 LET-Neg, Follow-up Period, n=180, 186
162 participants
167 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
2 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-2+, Follow-up Period, n=180, 186
8 participants
4 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
3 participants
2 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

Outcome measures
Measure
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.
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.
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Clear, Baseline Period, n=233, 229
188 participants
197 participants
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Cloudy, Baseline Period, n=233, 229
23 participants
21 participants
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Turbid, Baseline Period, n=233, 229
22 participants
11 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
134 participants
139 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
31 participants
33 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
17 participants
9 participants
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine App.-Clear, Follow-up Period, n=180, 186
139 participants
137 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
25 participants
35 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
16 participants
14 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
214 participants
213 participants
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
Urine Color-DY, Baseline Period, n=233, 229
11 participants
8 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
6 participants
7 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
154 participants
155 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
22 participants
19 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
6 participants
7 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
156 participants
160 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
18 participants
19 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

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

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