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Phase 4 Completed N=910 Randomized Quadruple-blind Treatment

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

Rhinitis, Allergic, Perennial
Source: ClinicalTrials.gov NCT00570492 ↗
Enrolled (actual)
910
Serious AEs
1.3%
Results posted
Feb 2012
Primary outcomePrimary: 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; 5.19 Centimeters per year (cm/year)

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.

Outcome Measures

OutcomeResultp-value
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
5.46; 5.19
SECONDARY
Mean 24-hour Urinary Free Cortisol Excretion
9.771; 9.242; 11.340; 11.125; 10.615; 10.311
SECONDARY
Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results
1; 0; 190; 187; 0; 1
SECONDARY
Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
246.8; 249.8; 261.9; 262.9; 264.2; 264.6
SECONDARY
Mean Values for the Laboratory Parameters if Albumin and Total Protein
45.8; 46.0; 45.7; 45.9; 45.8; 45.6
SECONDARY
Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine
6.9; 7.2; 7.2; 7.7; 7.0; 7.1
SECONDARY
Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)
4.83; 4.86; 4.82; 4.78; 4.87; 4.85
SECONDARY
Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts
0.026; 0.025; 0.026; 0.027; 0.026; 0.025
SECONDARY
Mean Values for Hemoglobin
129.5; 128.4; 131.8; 130.8; 132.1; 130.0
SECONDARY
Mean Values for Hematocrit
0.3823; 0.3783; 0.3904; 0.3873; 0.3906; 0.3844
SECONDARY
Mean Hematology Values for Red Blood Cells (RBCs)
4.59; 4.54; 4.56; 4.53; 4.57; 4.50
SECONDARY
Mean Values for Urine pH
6.02; 6.00; 6.02; 6.05; 6.05; 6.05
SECONDARY
Mean Values for Urine Specific Gravity
1.0240; 1.0234; 1.0244; 1.0234; 1.0237; 1.0242
SECONDARY
Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite
233; 229; 0; 0; 182; 181
SECONDARY
Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins
233; 229; 181; 181; 1; 0
SECONDARY
Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)
226; 226; 1; 0; 1; 0
SECONDARY
Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color
188; 197; 23; 21; 22; 11

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 o
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00570492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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