This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single \[predose\] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
ciclesonide nasal aerosol (74 mcg)
Placebo
West Coast Clinical Trials
Costa Mesa, California, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
Area under the concentration-time curve from time 0 to 24 hours \[AUC(0-24h)\]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
Time frame: Week 0 and 6
Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine
Time frame: weeks 0-6
Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine
Time frame: weeks 0-6
Number of Subjects Experiencing AEs
Time frame: weeks 0-6
Percentage of Subjects Experiencing AEs
Time frame: weeks 0-6
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Local Treatment-Emergent Adverse Events (ITT Population)
Time frame: weeks 0-6
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Local Treatment-Emergent Adverse Events (ITT Population)
Time frame: weeks 0-6
AUC(0-24h)
Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.
Time frame: Week 6
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Western Sky Medical Research
El Paso, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvania Research Associates
San Antonio, Texas, United States
Maximum Observed Concentration
Cmax (ng/mL) (PK Population)
Time frame: Week 6
Time to the Occurrence of Cmax
tmax (hour) (PK Population)
Time frame: Week 6
Terminal Half Life (t1/2)
Terminal half-life (t1/2) (hour)
Time frame: Weeks 6
Apparent Clearance of the Drug (CL/F)
CL/F liter per hour (L/hour) is the apparent clearance of the drug
Time frame: Week 6
Apparent Volume of Distribution (Vz/F)
Vz/F Liters (L) is the apparent volume of distribution
Time frame: Week 6
Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations
Time frame: weeks 0-6
Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Time frame: weeks 0-6
Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
Time frame: weeks 0-6
Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Time frame: weeks 0-6