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

Allergic Rhinitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163488
• Other study ID #: BY9010/M1-409
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 2, 2016
• Start date: January 2005
• Est. completion date: August 2005

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Hay Fever
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
United States	Altana Pharma/Nycomed	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety.
Secondary	safety and tolerability.

External Links

•   BY9010-M1-409-RDS-2005-12-12.pdf