Conditions: Perennial Allergic Rhinitis
Keywords: PAR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 737
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: ciclesonide nasal aerosol 74 mcg arm 2: ciclesonide nasal spray 200 mcg

Interventions: intervention 1: ciclesonide nasal aerosol intervention 2: ciclesonide nasal spray
Intervention descriptions: intervention 1: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol) intervention 2: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

Protocol document: