Clinical Trial: Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients (18-
Brief Summary: The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal spray.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: 24 h plasma cortisol profiles and urinary cortisol [ Time Frame: 53 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 24-hour urinary cortisol will be monitored at the following times [ Time Frame: 53 days ]
- Adverse events [ Time Frame: 53 days ]
- vital signs [ Time Frame: 53 days ]
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: April 14, 2008
Date Started: December 2004
Date Completion:
Last Updated: November 30, 2016
Last Verified: October 2016