Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Drug: Placebo nasal spray
- Registration Number
- NCT00570492
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluticasone furoate nasal spray Fluticasone furoate nasal spray - Placebo nasal spray Placebo nasal spray -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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.
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).
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.
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.
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.
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.
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 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 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 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.
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 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).
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇪Lima, Peru