Study identifier:BY9010/M1-490
ClinicalTrials.gov identifier:NCT00806754
EudraCT identifier:N/A
CTIS identifier:N/A
Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 years or older) with Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy
Rhinitis, Allergic, perennial
Phase 4
No
Ciclesonide nasal spray + placebo Azelastine, Ciclesonide nasal spray + Azelastine
All
340
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: 1 Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and placebo azelastine nasal spray ( two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening. | Drug: Ciclesonide nasal spray + placebo Azelastine Ciclesonide nasal spray 50 mcg + Placebo Azelastine |
Active Comparator: 2 Ciclesonide nasal spray (50 mcg/spray, one spray per nostril) and azelastine nasal spray (137 mcg/spray, two sprays per nostril) administered twice daily approximately 1 minute apart, once in the morning and 12 hours later, in the evening. | Drug: Ciclesonide nasal spray + Azelastine Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg |