Rhinitis, Allergic, Perennial
Conditions
Keywords
allergic rhinitis, fluticasone furoate nasal spray, growth
Brief summary
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.
Interventions
Fluticasone furoate nasal spray 110mg QD
DRUGPlacebo nasal spray
Placebo nasal spray
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent obtained from the subject's legal parent/guardian. Adequate provisions for assent of children should be provided in accordance with the IRB and any local governance. * Age: 5 to less than 7.5 years for females and 5 to less than 8.5 years for males at Visit 1. * Subjects must have a diagnosis and history of perennial allergic rhinitis (PAR) as follows: * At least a one year clinical history and treatment of PAR (written or verbal confirmation from the treating physician) and, * A documented, positive skin test to an appropriate perennial allergen (animal dander, house dust mites, cockroaches and/or mold) or documented, historical, in vitro test results for a specific IgE (such as RAST, PRIST) within the past 12 months prior to Visit 1 will be allowed. A positive skin test during Visit 1 will also be allowed. A positive skin test is defined as a wheal 3mm larger than the diluent control for prick testing. Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) and/or non-allergic rhinitis (NAR) are eligible for randomization. * At Visit 2, the daily rTNSS on any 4 of the last 7 days prior to Visit 2 must be 5. Subjects should refrain from using rescue medication during the 7 days prior to Visit 2. * Pre-pubescence: Tanner Staging equal to 1 for all classifications as assessed by the investigator during each of the five baseline study visits (Visit 1 through Visit 5). The same investigator should perform this assessment throughout the study for a respective subject, if possible, for consistency of assessment. Details are provided in the SPM. * Current height measurement via standardized stadiometer is within the 3rd and 97th percentile according to the CDC and any local longitudinal standard height charts for age and gender as provided in the SPM (Visit 1 through Visit 5). * Body weight and body mass index between the 3rd and 97th percentile according to the US CDC standards and any local standards as assessed during each of the five baseline study visits (Visit 1 through Visit 5). The US CDC standards are provided in the SPM. * Compliance: Subject's parent/guardian is literate and both subject and parent/guardian are deemed capable of complying with all study procedures to include proper study drug administration, daily e-diary completion, in-clinic laboratory assessments, and in-home 24 hour urine collection during the 76 weeks of study participation (Visit 1 through Visit 5).
Exclusion criteria
* A history or evidence of abnormal growth. Any previous or current condition that affects growth, including sleep disorders. * Asthma, with the exception of mild intermittent asthma \[National Asthma Education and Prevention Program, 2007\] (Note: Subjects will be allowed to use short-acting inhaled beta2 agonists only on an as needed basis.) * A history of nasal or sinus surgery, septal perforation, or severe obstruction in the nose (e.g. nasal polyps). * Any other significant concomitant medical condition. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study. (Visit 1 through Visit 5) * Any prior or current use of any medication/treatment that might affect growth including, but not limited to, methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, biphosphonates, anticonvulsants or phosphate binding antacids. (Visit 1 through Visit 5). * Use of corticosteroids, defined as: * Inhaled, intranasal, or high potency topical (to include dermatological, optic and otic) corticosteroids within 6 weeks prior to Visit 1 or during the baseline period (Visit 1 through Visit 5). * Systemic corticosteroids (to include oral and injectable) within 12 weeks prior to Visit 1 or during the baseline period (Visit 1 through Visit 5). * Use of other allergy medications within an appropriate timeframe relative to Visit 1 to allow the medication to be eliminated or no longer producing an effect as well as during the baseline period (Visit 1 through Visit 5) including, but not limited to: * Intranasal cromolyn - 14 days * Short-acting prescription and OTC antihistamines - 3 days * Long acting (second-generation) antihistamines (other than the loratadine syrup supplied by GSK to treat uncontrolled symptoms of PAR) including fexofenadine, cetirizine, desloratadine, and astemizole - 10 days * Long-acting antihistamine: astemizole - 12 weeks * Intranasal antihistamines (e.g. azelastine) -2 weeks * Oral or intranasal decongestants - 3 days * Intranasal, oral or inhaled anticholinergics - 3 days * Oral antileukotrienes - 3 days * Subcutaneous omalizumab - 5 months * Immunotherapy initiated or adjusted within 30 days prior to Visit 1 or during the baseline period (Visit 1 through Visit 5) noting that no significant changes in the dose, concentration or dilution will be allowed during the study. * Use of immunosuppressive medications 8 weeks prior to screening or during the baseline period (Visit 1 through Visit 5) of the study. * Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole. (Visit 1 through Visit 5) * Allergy/Intolerance * Known hypersensitivity to corticosteroids or any excipients in the nasal spray * Known hypersensitivity to the antihistamine or decongestant being provided for worsening symptoms of rhinitis during the conduct of the study. * Exposure to varicella (Chickenpox) or measles during the 3 weeks prior to screening or during the baseline period (Visit 1 through Visit 5), if non-immune. A diagnosis of varicella or measles during the baseline period is exclusionary as well. * Recent exposure to an investigational study drug within 30 days prior toVisit 1. * Affiliation with investigational site. * Findings of a clinically significant, abnormal screening (Visit 1) clinical laboratory test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Values for Urine pH | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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). |
| Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52) | 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). |
| Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST. |
| Mean Values for the Laboratory Parameters if Albumin and Total Protein | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein. |
| Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine. |
| Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN. |
| Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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. |
| Mean 24-hour Urinary Free Cortisol Excretion | 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) | 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. |
| Mean Values for Hematocrit | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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). |
| Mean Hematology Values for Red Blood Cells (RBCs) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | RBCs was assessed in participants at the indicated time points. |
| Mean Values for Urine Specific Gravity | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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. |
| Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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. |
| Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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. |
| Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET) | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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. |
| Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | 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). |
| Mean Values for Hemoglobin | Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60) | Hemoglobin was assessed in participants at the indicated time points. |
Countries
Argentina, Canada, Chile, France, Italy, Peru, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 237 |
| FFNS 110 mcg 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. | 237 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 16-week Single-blind Baseline Period | Adverse Event | 1 | 0 | 0 |
| 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 | Lost to Follow-up | 2 | 0 | 0 |
| 16-week Single-blind Baseline Period | Protocol Violation | 15 | 0 | 0 |
| 16-week Single-blind Baseline Period | Randomized but Did'nt Receive Treatment | 1 | 0 | 0 |
| 16-week Single-blind Baseline Period | Withdrawal by Subject | 56 | 0 | 0 |
| 52-week Double-blind Treatment Period | Adverse Event | 0 | 5 | 5 |
| 52-week Double-blind Treatment Period | Lack of Efficacy | 0 | 3 | 0 |
| 52-week Double-blind Treatment Period | Lost to Follow-up | 0 | 5 | 7 |
| 52-week Double-blind Treatment Period | Physician Decision | 0 | 2 | 4 |
| 52-week Double-blind Treatment Period | Protocol Violation | 0 | 12 | 15 |
| 52-week Double-blind Treatment Period | Reached Protocol-defined Stop Criteria | 0 | 3 | 0 |
| 52-week Double-blind Treatment Period | Withdrawal by Subject | 0 | 20 | 20 |
Baseline characteristics
| Characteristic | Placebo | FFNS 110 mcg | Total |
|---|---|---|---|
| Age, Continuous | 6.61 Years STANDARD_DEVIATION 0.969 | 6.64 Years STANDARD_DEVIATION 0.933 | 6.63 Years STANDARD_DEVIATION 0.95 |
| Race/Ethnicity, Customized African Amc/African and Amc Indian or Alk N | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized African Amc/African Heritage and White | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized African American (Amc)/African Heritage | 16 participants | 12 participants | 28 participants |
| Race/Ethnicity, Customized Amc Indian or Alaska Native (Alk N) | 19 participants | 18 participants | 37 participants |
| Race/Ethnicity, Customized Amc Indian or Alk N and White | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 7 participants | 5 participants | 12 participants |
| Race/Ethnicity, Customized Asian and White | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Native Hawaiian/ Other Pacific Islander and White | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 189 participants | 199 participants | 388 participants |
| Sex: Female, Male Female | 73 Participants | 75 Participants | 148 Participants |
| Sex: Female, Male Male | 164 Participants | 162 Participants | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 135 / 237 | 129 / 237 |
| serious Total, serious adverse events | 4 / 237 | 2 / 237 |
Outcome results
Primary
Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (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.
Time frame: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 0.1 |
| FFNS 110 mcg | 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 0.1 |
95% CI: [-0.48, -0.06]
Secondary
Mean 24-hour Urinary Free Cortisol Excretion
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 0.187 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 59.5 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Hematology Values for Red Blood Cells (RBCs)
RBCs was assessed in participants at the indicated time points.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Values for Hematocrit
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Hematocrit | Baseline Period, n=231, 231 | 0.3823 Percentage of BV occupied by RBCs | Standard Deviation 0.02296 |
| Placebo | Mean Values for Hematocrit | DB Treatment Period, n=186, 188 | 0.3904 Percentage of BV occupied by RBCs | Standard Deviation 0.02291 |
| Placebo | Mean Values for Hematocrit | Follow-up Period, n=177, 180 | 0.3906 Percentage of BV occupied by RBCs | Standard Deviation 0.02227 |
| FFNS 110 mcg | Mean Values for Hematocrit | Baseline Period, n=231, 231 | 0.3783 Percentage of BV occupied by RBCs | Standard Deviation 0.0248 |
| FFNS 110 mcg | Mean Values for Hematocrit | DB Treatment Period, n=186, 188 | 0.3873 Percentage of BV occupied by RBCs | Standard Deviation 0.02481 |
| FFNS 110 mcg | Mean Values for Hematocrit | Follow-up Period, n=177, 180 | 0.3844 Percentage of BV occupied by RBCs | Standard Deviation 0.02416 |
Secondary
Mean Values for Hemoglobin
Hemoglobin was assessed in participants at the indicated time points.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Hemoglobin | Baseline Period, n=231, 231 | 129.5 g/L | Standard Deviation 7.87 |
| Placebo | Mean Values for Hemoglobin | DB Treatment Period, n=186, 188 | 131.8 g/L | Standard Deviation 7.32 |
| Placebo | Mean Values for Hemoglobin | Follow-up Period, n=177, 180 | 132.1 g/L | Standard Deviation 7.43 |
| FFNS 110 mcg | Mean Values for Hemoglobin | Baseline Period, n=231, 231 | 128.4 g/L | Standard Deviation 8 |
| FFNS 110 mcg | Mean Values for Hemoglobin | DB Treatment Period, n=186, 188 | 130.8 g/L | Standard Deviation 7.77 |
| FFNS 110 mcg | Mean Values for Hemoglobin | Follow-up Period, n=177, 180 | 130.0 g/L | Standard Deviation 7.9 |
Secondary
Mean Values for the Laboratory Parameters if Albumin and Total Protein
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 4.3 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 8.5 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 1.9 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 0.84 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 0.69 |
| FFNS 110 mcg | 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 0.72 |
| FFNS 110 mcg | 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 0.7 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 0.082 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 3.4 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Mean Values for Urine pH
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Urine pH | Baseline Period, n=233, 229 | 6.02 scores on a scale | Standard Deviation 0.477 |
| Placebo | Mean Values for Urine pH | DB Treatment Period, n=182, 181 | 6.02 scores on a scale | Standard Deviation 0.547 |
| Placebo | Mean Values for Urine pH | Follow-up Period, n=180, 186 | 6.05 scores on a scale | Standard Deviation 0.538 |
| FFNS 110 mcg | Mean Values for Urine pH | Baseline Period, n=233, 229 | 6.00 scores on a scale | Standard Deviation 0.536 |
| FFNS 110 mcg | Mean Values for Urine pH | DB Treatment Period, n=182, 181 | 6.05 scores on a scale | Standard Deviation 0.507 |
| FFNS 110 mcg | Mean Values for Urine pH | Follow-up Period, n=180, 186 | 6.05 scores on a scale | Standard Deviation 0.524 |
Secondary
Mean Values for Urine Specific Gravity
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Urine Specific Gravity | Baseline Period, n=233, 229 | 1.0240 ratio | Standard Deviation 0.00718 |
| Placebo | Mean Values for Urine Specific Gravity | DB Treatment Period, n=182, 181 | 1.0244 ratio | Standard Deviation 0.00695 |
| Placebo | Mean Values for Urine Specific Gravity | Follow-up Period, n=180, 186 | 1.0237 ratio | Standard Deviation 0.00642 |
| FFNS 110 mcg | Mean Values for Urine Specific Gravity | Baseline Period, n=233, 229 | 1.0234 ratio | Standard Deviation 0.00673 |
| FFNS 110 mcg | Mean Values for Urine Specific Gravity | DB Treatment Period, n=182, 181 | 1.0234 ratio | Standard Deviation 0.00649 |
| FFNS 110 mcg | Mean Values for Urine Specific Gravity | Follow-up Period, n=180, 186 | 1.0242 ratio | Standard Deviation 0.00672 |
Secondary
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, Improved | 1 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, Worsened | 0 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, Worsened | 0 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, Improved | 1 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, Improved | 0 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, No Change | 190 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, No Change | 190 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, Worsened | 0 participants |
| Placebo | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, No Change | 191 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, Worsened | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, Improved | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, No Change | 187 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, Improved | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, No Change | 188 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Ulcers, Worsened | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, Improved | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Polyps, No Change | 188 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results | Mucosal Bleeding, Worsened | 1 participants |
Secondary
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Urine Nitrite-Neg, Baseline Period, n=233, 229 | 232 participants |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, DB Treatment Period, n=182, 181 | 0 participants |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Urine Nitrite-Pos, Baseline Period, n=233, 229 | 1 participants |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, Baseline Period, n=233, 229 | 233 participants |
| Placebo | 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 |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, Follow-up Period, n=180, 186 | 180 participants |
| Placebo | 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 |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, DB Treatment Period, n=182, 181 | 182 participants |
| Placebo | 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 |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, Follow-up Period, n=180, 186 | 0 participants |
| Placebo | 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 |
| Placebo | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, Baseline Period, n=233, 229 | 0 participants |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, Baseline Period, n=233, 229 | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, DB Treatment Period, n=182, 181 | 181 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, DB Treatment Period, n=182, 181 | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, Follow-up Period, n=180, 186 | 186 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Pos, Follow-up Period, n=180, 186 | 0 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Urine Nitrite-Neg, Baseline Period, n=233, 229 | 228 participants |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | Urine Nitrite-Pos, Baseline Period, n=233, 229 | 1 participants |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite | UB-Neg, Baseline Period, n=233, 229 | 229 participants |
Secondary
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
Secondary
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |
| FFNS 110 mcg | 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 |