Clinical Trial: Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-blind, Randomized, Placebo-controlled, Parallel Group, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Y
Brief Summary: The primary objective of this study is to demonstrate the efficacy of ciclesonide HFA, applied as a nasal aerosol once daily, in patients with SAR. 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 the first two weeks of treatment [ Time Frame: 2 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment [ Time Frame: 2 weeks ]
- Physician-assessed total nasal symptoms score (PNSS) over the treatment period [ Time Frame: 4 weeks ]
- Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0 [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: December 10, 2008
Date Started: April 2007
Date Completion:
Last Updated: December 2, 2016
Last Verified: September 2016
