drugset / Trial / NCT00659048

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)

NCT00659048

Phase 3 Completed 106 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-12
Primary completion
2005-04
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciclesonide Other / unclassified 200 ug Intranasal