Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long T... | NCT00570492

NCT00570492

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Placebo nasal spray	Placebo Comparator		Drug: Placebo nasal spray
Fluticasone furoate nasal spray	Experimental		Drug: Fluticasone furoate nasal spray

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone furoate nasal spray	Drug	Fluticasone furoate nasal spray 110mg QD	Fluticasone furoate nasal spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Oxford	Alabama	36203	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25017530	Derived	Lee LA, Sterling R, Maspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
FFR101782	Annotated Case Report Form	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo: Baseline Period	Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
FG001	Placebo: Double-blind Treatment Period

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG000910 subjects
FG0010 subjects
FG0020 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0006.61± 0.969 BG0016.64± 0.933 BG0026.63± 0.950

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00073 BG001

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

African American (Amc)/African Heritage

Title	Measurements
	BG00016 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period

Posted

Least Squares Mean

Standard Error

Centimeters per year (cm/year)

Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000218 OG001217

Title

Denominators

Categories

Title	Measurements
	OG0005.46± 0.10 OG0015.19± 0.10

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Final Values)	-0.270			2-Sided	95	-0.48	-0.06			An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.		Superiority or Other

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.

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.

Posted

Mean

Standard Deviation

Micrograms per 24 hours (mcg/24 hours)

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)

ID	Title	Description
OG000	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.
OG001	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.

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).

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.

Posted

Number

participants

Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

International Units per liter (IU/L)

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Grams per liter (g/L)

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Micromoles (µmol)/L

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Units

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Millimoles (mmol)/L

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Giga (10^9) cells (Gi)/L

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Mean Values for Hemoglobin

Hemoglobin was assessed in participants at the indicated time points.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

g/L

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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).

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Percentage of BV occupied by RBCs

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

Mean Hematology Values for Red Blood Cells (RBCs)

RBCs was assessed in participants at the indicated time points.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

Trillion (10^12) cells (Ti)/L

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

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).

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

scores on a scale

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Mean

Standard Deviation

ratio

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Number

participants

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Number

participants

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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.

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Number

participants

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

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).

ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.

Posted

Number

participants

Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			4	237	135	237
EG001	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.			2	237	129	237

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected237 at risk EG0011 affected237 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected237 at risk EG0011 affected237 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected237 at risk EG0010 affected237 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00041 affected237 at risk EG00137 affected237 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00024 affected237 at risk EG00134 affected237 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00018 affected237 at risk EG00112 affected237 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected237 at risk EG00112 affected237 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00014 affected237 at risk EG00111 affected237 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected237 at risk EG00113 affected237 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected237 at risk EG00114 affected237 at risk
Acute Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected237 at risk EG0013 affected237 at risk
Tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected237 at risk EG0018 affected237 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected237 at risk EG0019 affected237 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected237 at risk EG0013 affected237 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00022 affected237 at risk EG00116 affected237 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00015 affected237 at risk EG00114 affected237 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected237 at risk EG0017 affected237 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00014 affected237 at risk EG00121 affected237 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected237 at risk EG0018 affected237 at risk

ID	Term
D012221	Rhinitis, Allergic, Perennial
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Units	Counts
Participants	OG000228 OG001231

Units	Counts
Participants	OG000233 OG001229

Units	Counts
Participants	OG000233 OG001229