This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
737
ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)
ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Time frame: 0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
CHOC PSF AMC - Division of Allergy, Asthma and Immunology
Orange, California, United States
Allergy Associates Medical Group Inc.
San Diego, California, United States
Bensch Research Associates
Stockton, California, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
DataQuest Medical Research LLC
Lawerenceville, Georgia, United States
Asthma & Allergy Consultants, PC
Lilburn, Georgia, United States
Gordon D Raphael, MD
Bethesda, Maryland, United States
Medical Education and Research Management Services of New England
Gardner, Massachusetts, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
...and 21 more locations
Time frame: 0-6 months
Number of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
Percentage of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months