Clinical Trial: To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200 mg Once Daily) in the Treatment o
Brief Summary: The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with PAR. The secondary objectives are to evaluate Quality-of-Life and safety.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment. [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment. [ Time Frame: 6 weeks ]
- Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint. [ Time Frame: 6 weeks ]
- RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: April 14, 2008
Date Started: December 2003
Date Completion:
Last Updated: December 1, 2016
Last Verified: October 2016
