CompletedNCT00570492Updated Sep 15, 2017Results posted

Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.

A Phase 4 interventional study of Fluticasone furoate nasal spray and Placebo nasal spray in Rhinitis, Allergic, Perennial, sponsored by GlaxoSmithKline. Completed at 74 sites in 7 countries. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 474
Allocation: Randomized
Ages: 5 Years to 8 Years
Sex: All

Study 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.

Conditions studied

Rhinitis, Allergic, Perennial

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Keywords

allergic rhinitis
fluticasone furoate nasal spray
growth

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 474 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 5 Years to 8 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 474 participants (actual)

Study arms

Placebo comparator
Placebo nasal spray
Drug: Placebo nasal spray
Experimental
Fluticasone furoate nasal spray
Drug: Fluticasone furoate nasal spray

Interventions

DrugFluticasone furoate nasal spray
Fluticasone furoate nasal spray 110mg QD
DrugPlacebo nasal spray
Placebo nasal spray

What researchers measure

Primary outcomes

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)

Secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results

Posted Feb 7, 2012

Participant flow

16-week Single-blind Baseline Period

Participant flow — 16-week Single-blind Baseline Period
Milestone	Placebo: Baseline Period	Placebo: Double-blind Treatment Period	FFNS 110 mcg: Double-blind Treatment Period
Started	910	0	0
Completed	474	0	0
Not completed	436	0	0
Withdrew: Didn't meet inclusion/exclusion criteria	98	0	0
Withdrew: Didn't meet randomization criteria	263	0	0
Withdrew: Withdrawal by subject	56	0	0
Withdrew: Protocol violation	15	0	0
Withdrew: Lost to follow-up	2	0	0
Withdrew: Adverse event	1	0	0
Withdrew: Randomized but did'nt receive treatment	1	0	0

52-week Double-blind Treatment Period

Participant flow — 52-week Double-blind Treatment Period
Milestone	Placebo: Double-blind Treatment Period	FFNS 110 mcg: Double-blind Treatment Period
Started	237	237
Completed	187	186
Not completed	50	51
Withdrew: Withdrawal by subject	20	20
Withdrew: Protocol violation	12	15
Withdrew: Lost to follow-up	5	7
Withdrew: Adverse event	5	5
Withdrew: Physician decision	2	4
Withdrew: Lack of efficacy	3	0
Withdrew: Reached protocol-defined stop criteria	3	0

Outcome measures

PrimaryChange 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)
Reported as:: Least squares mean · Centimeters per year (cm/year)

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

Statistical analysis

Placebo vs FFNS 110 mcg · Mean difference (final values): -0.270 · 95% CI -0.48 to -0.06An 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.

SecondaryMean 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)
Reported as:: Mean · Micrograms per 24 hours (mcg/24 hours)

Mean 24-hour Urinary Free Cortisol Excretion
Micrograms per 24 hours (mcg/24 hours)	Placebo	FFNS 110 mcg
End of 16-week Baseline Period, n=168, 172	9.771 ± 6.0479	9.242 ± 5.5821
End of 52-week DB Treatment Period, n=163, 169	11.340 ± 9.6775	11.125 ± 9.2195
End of 8-week Follow-up Period, n=161, 167	10.615 ± 6.6903	10.311 ± 5.9986

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
participants	Placebo	FFNS 110 mcg
Mucosal Bleeding, Improved	1	0
Mucosal Bleeding, No Change	190	187
Mucosal Bleeding, Worsened	0	1
Ulcers, Improved	0	0
Ulcers, No Change	191	188
Ulcers, Worsened	0	0
Polyps, Improved	1	0
Polyps, No Change	190	188
Polyps, Worsened	0	0

SecondaryMean 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)
Reported as:: Mean · International Units per liter (IU/L)

Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
International Units per liter (IU/L)	Placebo	FFNS 110 mcg
Alk P, Baseline Period, n=231, 234	246.8 ± 57.45	249.8 ± 67.81
Alk P, DB Treatment Period, n=184, 182	261.9 ± 61.96	262.9 ± 71.22
Alk P, Follow-up Period, n=175, 174	264.2 ± 59.67	264.6 ± 67.44
ALT, Baseline Period, n=231, 234	14.8 ± 4.54	15.1 ± 4.73
ALT, DB Treatment Period, n=184, 182	15.9 ± 8.50	15.8 ± 5.12
ALT, Follow-up Period, n=175, 174	16.7 ± 14.41	17.2 ± 13.15
AST, Baseline Period, n=229, 232	27.4 ± 4.89	28.1 ± 4.89
AST, DB Treatment Period, n=175, 179	27.0 ± 5.49	27.6 ± 4.87
AST, Follow-up Period, n=169, 174	27.7 ± 8.93	28.3 ± 10.44

SecondaryMean 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)
Reported as:: Mean · Grams per liter (g/L)

Mean Values for the Laboratory Parameters if Albumin and Total Protein
Grams per liter (g/L)	Placebo	FFNS 110 mcg
Albumin, Baseline Period, n=231, 234	45.8 ± 2.29	46.0 ± 2.33
Albumin, DB Treatment Period, n=184, 182	45.7 ± 2.24	45.9 ± 2.25
Albumin, Follow-up Period, n=175, 175	45.8 ± 2.31	45.6 ± 2.36
Total Protein, Baseline Period, n=231, 234	72.0 ± 3.78	71.9 ± 4.30
Total Protein, DB Treatment Period, n=184, 182	71.7 ± 3.76	71.7 ± 3.95
Total Protein, Follow-up Period, n=175, 175	71.5 ± 3.66	71.5 ± 3.83

SecondaryMean 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)
Reported as:: Mean · Micromoles (µmol)/L

Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
Micromoles (µmol)/L	Placebo	FFNS 110 mcg
Total Bilirubin, Baseline Period, n=231, 234	6.9 ± 2.43	7.2 ± 3.40
Total Bilirubin, DB Treatment Period, n=184, 182	7.2 ± 2.69	7.7 ± 3.56
Total Bilirubin, Follow-up Period, n=175, 175	7.0 ± 2.72	7.1 ± 3.14
Creatinine, Baseline Period, n=231, 234	43.3 ± 7.98	43.6 ± 7.96
Creatinine, DB Treatment Period, n=184, 182	45.0 ± 8.34	44.6 ± 8.16
Creatinine, Follow-up Period, n=175, 175	44.5 ± 7.38	45.0 ± 7.72

SecondaryMean 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)
Reported as:: Mean · Millimoles (mmol)/L

Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
Millimoles (mmol)/L	Placebo	FFNS 110 mcg
Glucose, Baseline Period, n=230, 231	4.83 ± 0.683	4.86 ± 0.690
Glucose, DB Treatment Period, n=184, 182	4.82 ± 0.782	4.78 ± 0.720
Glucose, Follow-up Period, n=175, 175	4.87 ± 0.840	4.85 ± 0.700
Calcium, Baseline Period, n=229, 232	2.441 ± 0.0786	2.435 ± 0.0993
Calcium, DB Treatment Period, n=175, 179	2.437 ± 0.0776	2.440 ± 0.0847
Calcium, Follow-up Period, n=169, 173	2.438 ± 0.0769	2.436 ± 0.0820
Potassium, Baseline Period, n=229, 232	4.30 ± 0.404	4.31 ± 0.437
Potassium, DB Treatment Period, n=175, 179	4.30 ± 0.373	4.30 ± 0.345
Potassium, Follow-up Period, n=169, 173	4.28 ± 0.362	4.32 ± 0.409
Sodium, Baseline Period, n=231, 234	139.4 ± 1.90	139.3 ± 1.83
Sodium, DB Treatment Period, n=184, 182	139.1 ± 1.65	139.2 ± 1.58
Sodium, Follow-up Period, n=175, 175	139.3 ± 1.89	139.4 ± 2.19
Urea/BUN, Baseline Period, n=231, 235	4.99 ± 1.897	4.77 ± 1.195
Urea/BUN, DB Treatment Period, n=184, 182	4.82 ± 1.315	4.82 ± 1.294
Urea/BUN, Follow-up Period, n=175, 175	4.93 ± 1.219	4.75 ± 1.274

SecondaryMean 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)
Reported as:: Mean · Giga (10^9) cells (Gi)/L

Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
Giga (10^9) cells (Gi)/L	Placebo	FFNS 110 mcg
Basophil, Baseline Period, n=228, 231	0.026 ± 0.0176	0.025 ± 0.0151
Basophil, DB Treatment Period, n=186, 188	0.026 ± 0.0198	0.027 ± 0.0184
Basophil, Follow-up Period, n=177, 179	0.026 ± 0.0172	0.025 ± 0.0165
Eosinophil, Baseline Period, n=228, 231	0.395 ± 0.3292	0.455 ± 0.3859
Eosinophil, DB Treatment Period, n=186, 188	0.442 ± 0.3505	0.394 ± 0.3577
Eosinophil, Follow-up Period, n=177, 179	0.419 ± 0.3337	0.409 ± 0.3296
Lymphocyte, Baseline Period, n=228, 231	3.046 ± 0.9686	2.987 ± 0.9158
Lymphocyte, DB Treatment Period, n=177, 179	2.779 ± 0.8038	2.820 ± 0.8424
Lymphocyte, Follow-up Period, n=169, 173	2.871 ± 0.8784	2.841 ± 0.8107
WBC, Baseline Period, n=228, 231	7.71 ± 2.077	7.36 ± 1.818
WBC, DB Treatment Period, n=186, 188	7.14 ± 1.899	6.98 ± 1.896
WBC, Follow-up Period, n=177, 179	7.18 ± 1.945	6.96 ± 1.894
Monocyte, Baseline Period, n=228, 231	0.348 ± 0.1655	0.373 ± 0.1870
Monocyte, DB Treatment Period, n=186, 188	0.320 ± 0.1393	0.343 ± 0.1598
Monocyte, Follow-up Period, n=177, 179	0.334 ± 0.1471	0.326 ± 0.1592
Segmented Neu, Baseline Period, n=228, 231	3.892 ± 1.6722	3.517 ± 1.5347
Segmented Neu, DB Treatment Period, n=186, 188	3.572 ± 1.5407	3.391 ± 1.4828
Segmented Neu, Follow-up Period, n=177, 179	3.572 ± 1.5623	3.354 ± 1.4379
Platelet, Baseline Period, n=230, 230	313.8 ± 70.19	314.1 ± 59.46
Platelet, DB Treatment Period, n=187, 187	278.6 ± 55.58	279.5 ± 49.51
Platelet, Follow-up Period, n=175, 180	276.4 ± 49.27	283.6 ± 59.50

SecondaryMean 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)
Reported as:: Mean · g/L

Mean Values for Hemoglobin
g/L	Placebo	FFNS 110 mcg
Baseline Period, n=231, 231	129.5 ± 7.87	128.4 ± 8.00
DB Treatment Period, n=186, 188	131.8 ± 7.32	130.8 ± 7.77
Follow-up Period, n=177, 180	132.1 ± 7.43	130.0 ± 7.90

SecondaryMean 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)
Reported as:: Mean · Percentage of BV occupied by RBCs

Mean Values for Hematocrit
Percentage of BV occupied by RBCs	Placebo	FFNS 110 mcg
Baseline Period, n=231, 231	0.3823 ± 0.02296	0.3783 ± 0.02480
DB Treatment Period, n=186, 188	0.3904 ± 0.02291	0.3873 ± 0.02481
Follow-up Period, n=177, 180	0.3906 ± 0.02227	0.3844 ± 0.02416

SecondaryMean 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)
Reported as:: Mean · Trillion (10^12) cells (Ti)/L

Mean Hematology Values for Red Blood Cells (RBCs)
Trillion (10^12) cells (Ti)/L	Placebo	FFNS 110 mcg
Baseline Period, n=231, 231	4.59 ± 0.312	4.54 ± 0.327
DB Treatment Period, n=186, 188	4.56 ± 0.303	4.53 ± 0.319
Follow-up Period, n=177, 180	4.57 ± 0.306	4.50 ± 0.314

SecondaryMean 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)
Reported as:: Mean · scores on a scale

Mean Values for Urine pH
scores on a scale	Placebo	FFNS 110 mcg
Baseline Period, n=233, 229	6.02 ± 0.477	6.00 ± 0.536
DB Treatment Period, n=182, 181	6.02 ± 0.547	6.05 ± 0.507
Follow-up Period, n=180, 186	6.05 ± 0.538	6.05 ± 0.524

SecondaryMean 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)
Reported as:: Mean · ratio

Mean Values for Urine Specific Gravity
ratio	Placebo	FFNS 110 mcg
Baseline Period, n=233, 229	1.0240 ± 0.00718	1.0234 ± 0.00673
DB Treatment Period, n=182, 181	1.0244 ± 0.00695	1.0234 ± 0.00649
Follow-up Period, n=180, 186	1.0237 ± 0.00642	1.0242 ± 0.00672

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
participants	Placebo	FFNS 110 mcg
UB-Neg, Baseline Period, n=233, 229	233	229
UB-Pos, Baseline Period, n=233, 229	0	0
UB-Neg, DB Treatment Period, n=182, 181	182	181
UB-Pos, DB Treatment Period, n=182, 181	0	0
UB-Neg, Follow-up Period, n=180, 186	180	186
UB-Pos, Follow-up Period, n=180, 186	0	0
Urine Nitrite-Neg, Baseline Period, n=233, 229	232	228
Urine Nitrite-Pos, Baseline Period, n=233, 229	1	1
Urine Nitrite-Neg, DB Treatment Period, n=182, 181	178	176
Urine Nitrite-Pos, DB Treatment Period, n=182, 181	4	5
Urine Nitrite-Neg, Follow-up Period, n=180, 186	179	183
Urine Nitrite-Pos, Follow-up Period, n=180, 186	1	3

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
participants	Placebo	FFNS 110 mcg
Urine Glucose-Neg, Baseline Period, n=233, 229	233	229
Urine Glucose-Neg, DB Treatment Period, n=182, 181	181	181
Urine Glucose-Tr, DB Treatment Period, n=182, 181	1	0
Urine Glucose-Neg, Follow-up Period, n=180, 186	179	186
Urine Glucose-1+, Follow-up Period, n=180, 186	1	0
Urine Ketones-Neg, Baseline Period, n=233, 229	231	227
Urine Ketones-Trace, Baseline Period, n=233, 229	0	1
Urine Ketones-1+, Baseline Period, n=233, 229	2	1
Urine Ketones-Neg, DB Treatment Period, n=182, 181	179	176
Urine Ketones-Tr, DB Treatment Period, n=182, 181	3	5
Urine Ketones-Neg, Follow-up Period, n=180, 186	180	184
Urine Ketones-Trace, Follow-up Period, n=180, 186	0	1
Urine Ketones-1+, Follow-up Period, n=180, 186	0	1
Urine Protein-Neg, Baseline Period, n=233, 229	218	207
Urine Protein-Trace, Baseline Period, n=233, 229	11	18
Urine Protein-1+, Baseline Period, n=233, 229	2	4
Urine Protein-2+, Baseline Period, n=233, 229	2	0
Urine Protein-Neg, DB Treatment Period, n=182, 181	145	152
Urine Protein-Tr, DB Treatment Period, n=182, 181	20	20
Urine Protein-1+, DB Treatment Period, n=182, 181	14	7
Urine Protein-2+, DB Treatment Period, n=182, 181	2	2
Urine Protein-3+, DB Treatment Period, n=182, 181	1	0
Urine Protein-Neg, Follow-up Period, n=180, 186	156	155
Urine Protein-Trace, Follow-up Period, n=180, 186	16	22
Urine Protein-1+, Follow-up Period, n=180, 186	6	8
Urine Ketones-2+, Follow-up Period, n=180, 186	1	1
Urine Ketones-3+, Follow-up Period, n=180, 186	1	0

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
participants	Placebo	FFNS 110 mcg
Urine OB-Neg, Baseline Period, n=233, 229	226	226
Urine OB-Small, Baseline Period, n=233, 229	1	0
Urine OB-Moderate, Baseline Period, n=233, 229	1	0
Urine OB-Trace, Baseline Period, n=233, 229	4	3
Urine OB-1+, Baseline Period, n=233, 229	1	0
Urine OB-Neg, DB Treatment Period, n=182, 181	178	178
Urine OB-Trace, DB Treatment Period, n=182, 181	4	1
Urine OB-1+, DB Treatment Period, n=182, 181	0	1
Urine OB-3+, DB Treatment Period, n=182, 181	0	1
Urine OB-Neg, Follow-up Period, n=180, 186	177	184
Urine OB-Trace, Follow-up Period, n=180, 186	1	1
Urine OB-1+, Follow-up Period, n=180, 186	2	0
Urine OB-2+, Follow-up Period, n=180, 186	0	1
Urine LET-Neg, Baseline Period, n=233, 229	220	219
Urine LET-Small, Baseline Period, n=233, 229	1	2
Urine LET-Moderate, Baseline Period, n=233, 229	0	1
Urine LET-Large, Baseline Period, n=233, 229	0	1
Urine LET-Trace, Baseline Period, n=233, 229	7	0
Urine LET-1+, Baseline Period, n=233, 229	3	2
Urine LET-2+, Baseline Period, n=233, 229	0	2
Urine LET-3+, Baseline Period, n=233, 229	2	2
Urine LET-Neg, DB Treatment Period, n=182, 181	170	163
Urine LET-Trace, DB Treatment Period, n=182, 181	5	4
Urine LET-1+, DB Treatment Period, n=182, 181	5	6
Urine LET-2+, DB Treatment Period, n=182, 181	2	7
Urine LET-3+, DB Treatment Period, n=182, 181	0	1
Urine LET-Neg, Follow-up Period, n=180, 186	162	167
Urine LET-Trace, Follow-up Period, n=180, 186	5	5
Urine LET-1+, Follow-up Period, n=180, 186	2	8
Urine LET-2+, Follow-up Period, n=180, 186	8	4
Urine LET-3+, Follow-up Period, n=180, 186	3	2

SecondaryNumber 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)
Reported as:: Number · participants

Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
participants	Placebo	FFNS 110 mcg
Urine App.-Clear, Baseline Period, n=233, 229	188	197
Urine App.-Cloudy, Baseline Period, n=233, 229	23	21
Urine App.-Turbid, Baseline Period, n=233, 229	22	11
Urine App.-Clear, DB Treatment Period, n=182, 181	134	139
Urine App.-Cloudy, DB Treatment Period, n=182, 181	31	33
Urine App.-Turbid, DB Treatment Period, n=182, 181	17	9
Urine App.-Clear, Follow-up Period, n=180, 186	139	137
Urine App.-Cloudy, Follow-up Period, n=180, 186	25	35
Urine App.-Turbid, Follow-up Period, n=180, 186	16	14
Urine Color-Straw, Baseline Period, n=233, 229	8	8
Urine Color-Yellow, Baseline Period, n=233, 229	214	213
Urine Color-DY, Baseline Period, n=233, 229	11	8
Urine Color-Straw, DB Treatment Period, n=182, 181	6	7
Urine Color-Yellow, DB Treatment Period, n=182,181	154	155
Urine Color-DY, DB Treatment Period, n=182, 181	22	19
Urine Color-Straw, Follow-up Period, n=180, 186	6	7
Urine Color-Yellow, Follow-up Period, n=180, 186	156	160
Urine Color-DY, Follow-up Period, n=180, 186	18	19

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	4/237 (1.7%)	135/237 (57%)
FFNS 110 mcg	—	2/237 (0.8%)	129/237 (54.4%)

Most frequent serious events

Most frequent serious events
Event	Placebo	FFNS 110 mcg
AppendicitisInfections and infestations	0/237	1/237
GastroenteritisInfections and infestations	0/237	1/237
OsteomyelitisInfections and infestations	1/237	0/237
Pneumonia Primary AtypicalInfections and infestations	1/237	0/237
Respiratory Tract Infection ViralInfections and infestations	1/237	0/237
Head InjuryInjury, poisoning and procedural complications	1/237	0/237
MyositisMusculoskeletal and connective tissue disorders	1/237	0/237
AsthmaRespiratory, thoracic and mediastinal disorders	1/237	0/237

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Placebo	FFNS 110 mcg
NasopharyngitisInfections and infestations	41/237	37/237
BronchitisInfections and infestations	24/237	34/237
EpistaxisRespiratory, thoracic and mediastinal disorders	22/237	16/237
PyrexiaGeneral disorders	14/237	21/237
PharyngitisInfections and infestations	18/237	12/237
Respiratory Tract Infection ViralInfections and infestations	17/237	12/237
CoughRespiratory, thoracic and mediastinal disorders	15/237	14/237
SinusitisInfections and infestations	14/237	11/237
InfluenzaInfections and infestations	8/237	14/237
Upper Respiratory Tract InfectionInfections and infestations	11/237	13/237

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	FFNS 110 mcg	Total
Mean	6.61 ± 0.969	6.64 ± 0.933	6.63 ± 0.950

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	FFNS 110 mcg	Total
Female	73	75	148
Male	164	162	326

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Placebo	FFNS 110 mcg	Total
African American (Amc)/African Heritage	16	12	28
Amc Indian or Alaska Native (Alk N)	19	18	37
Asian	7	5	12
Native Hawaiian or Other Pacific Islander	1	0	1
White	189	199	388
African Amc/African and Amc Indian or Alk N	1	0	1
African Amc/African Heritage and White	1	2	3
Amc Indian or Alk N and White	1	0	1
Asian and White	1	1	2
Native Hawaiian/ Other Pacific Islander and White	1	0	1

Study locations

74 sites

GSK Investigational Site
Oxford, Alabama 36203, United States
GSK Investigational Site
Little Rock, Arkansas 72205, United States
GSK Investigational Site
Huntington Beach, California 92647, United States
GSK Investigational Site
Long Beach, California 90806, United States
GSK Investigational Site
Long Beach, California 90808, United States
GSK Investigational Site
Riverside, California 92506, United States
GSK Investigational Site
Rolling Hills Estates, California 90274, United States
GSK Investigational Site
Vista, California 92083, United States
GSK Investigational Site
Coral Gables, Florida 33134, United States
GSK Investigational Site
Ocala, Florida 34471, United States
GSK Investigational Site
Tampa, Florida 33613, United States
GSK Investigational Site
Gainesville, Georgia 30501, United States
GSK Investigational Site
Lawrenceville, Georgia 30045, United States
GSK Investigational Site
Stockbridge, Georgia 30281, United States
GSK Investigational Site
Evansville, Indiana 47713, United States
GSK Investigational Site
Indianapolis, Indiana 46208, United States
GSK Investigational Site
Lenexa, Kansas 66215, United States
GSK Investigational Site
Metairie, Louisiana 70006, United States
GSK Investigational Site
Baltimore, Maryland 21236, United States
GSK Investigational Site
Ypsilanti, Michigan 48197, United States
GSK Investigational Site
Plymouth, Minnesota 55441, United States
GSK Investigational Site
Rolla, Missouri 65401, United States
GSK Investigational Site
Warrensburg, Missouri 64093, United States
GSK Investigational Site
Bellevue, Nebraska 68123-4303, United States
GSK Investigational Site
Omaha, Nebraska 68131, United States
GSK Investigational Site
Canton, Ohio 44718, United States
GSK Investigational Site
Sylvania, Ohio 43560, United States
GSK Investigational Site
Oklahoma City, Oklahoma 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma 73120, United States
GSK Investigational Site
Medford, Oregon 97504, United States
GSK Investigational Site
Portland, Oregon 97213, United States
GSK Investigational Site
Altoona, Pennsylvania 16801, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15212, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15241, United States
GSK Investigational Site
Upland, Pennsylvania 19013, United States
GSK Investigational Site
Charleston, South Carolina 29414, United States
GSK Investigational Site
Orangeburg, South Carolina 29118, United States
GSK Investigational Site
Spartanburg, South Carolina 29303, United States
GSK Investigational Site
Dallas, Texas 75230, United States
GSK Investigational Site
Dallas, Texas 75246, United States
GSK Investigational Site
El Paso, Texas 79903, United States
GSK Investigational Site
El Paso, Texas 79925, United States
GSK Investigational Site
Houston, Texas 77054, United States
GSK Investigational Site
Kerrville, Texas 78028, United States
GSK Investigational Site
San Antonio, Texas 78205, United States
GSK Investigational Site
San Antonio, Texas 78229, United States
GSK Investigational Site
Waco, Texas 76712, United States
GSK Investigational Site
South Burlington, Vermont 05403, United States
GSK Investigational Site
Richmond, Virginia 23219, United States
GSK Investigational Site
Richmond, Virginia 23229, United States
GSK Investigational Site
Nueve de Julio, Buenos Aires B6500BWQ, Argentina
GSK Investigational Site
Rosario, Santa Fe 2000, Argentina
GSK Investigational Site
Rosario, Santa Fe S2000DBS, Argentina
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Winnipeg, Manitoba R2M 5L9, Canada
GSK Investigational Site
Brampton, Ontario L6T 3T1, Canada
GSK Investigational Site
Mississauga, Ontario L5A 3V4, Canada
GSK Investigational Site
Toronto, Ontario M4V 1R2, Canada
GSK Investigational Site
Charlottetown, Prince Edward Island C1A 8T5, Canada
GSK Investigational Site
Quebec City, Quebec G1V 4M6, Canada
GSK Investigational Site
Trois Rivières, Quebec G8T 7A1, Canada
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Viña del Mar, Valparaíso, Chile
GSK Investigational Site
Laon, 02000, France
GSK Investigational Site
Le Havre, 76083, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Milano, Lombardia 20122, Italy
GSK Investigational Site
Milano, Lombardia 20129, Italy
GSK Investigational Site
Perugia, Umbria 06156, Italy
GSK Investigational Site
Lima, Lima 27, Peru

References and documents

Publications

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. PubMed 25017530 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00570492
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Dec 11, 2007
Start date: Nov 26, 2007
Primary completion: Mar 1, 2011
Completion: Mar 17, 2011
Results posted: Feb 7, 2012
Last update: Sep 15, 2017

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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