Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163488

Enrollment

106

Registered

2005-09-14

Start date

2005-01-31

Completion date

2005-08-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Hay Fever, Perennial Allergic Rhinitis

Keywords

Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Brief summary

The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.

Interventions

DRUGCiclesonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * General good health, other than perennial allergic rhinitis * History and diagnosis of perennial allergic rhinitis by skin prick * Normal body weight as defined by the study protocol Main

Exclusion criteria

* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period * Participation in any investigational drug trial within the 30 days preceding the Screening Visit * A known hypersensitivity to any corticosteroid or any of the excipients in the formulations * Use of any prohibited concomitant medications as defined by the study protocol * Previous participation in an intranasal ciclesonide study * Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Design outcomes

Primary

Measure	Time frame
safety.	—

Secondary

Measure	Time frame
safety and tolerability.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026