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

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00163488
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
History of Changes

September 12, 2005
May 4, 2012
January 2005
Not Provided
safety.
safety
Complete list of historical versions of study NCT00163488 on ClinicalTrials.gov Archive Site
safety and tolerability.
safety and tolerability
Not Provided
Not Provided
 
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Perennial Allergic Rhinitis
  • Allergic Rhinitis
  • Hay Fever
Drug: Ciclesonide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
August 2005
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00163488
BY9010/M1-409
Not Provided
Not Provided
Takeda Global Research & Development Center, Inc.
Not Provided
Study Chair: Mark A. Wingertzahn, Ph.D. Altana Pharma, Florham Park, NJ 07932, USA
Takeda Global Research & Development Center, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP