Clinical Trial: 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 (BY9010/M1-490)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Allerg
Brief Summary:
- The primary objective of this study is to evaluate the efficacy of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR) not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy
- The secondary objective is to investigate the safety of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the four weeks of treatment [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Total physician-assessed nasal symptoms score (PNSS) at Endpoint [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: December 10, 2008
Date Started: November 2006
Date Completion:
Last Updated: November 22, 2016
Last Verified: November 2016
