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
ClinicalTrials.gov Identifier:
NCT00163488
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • safety.

Secondary Outcome Measures:
  • safety and tolerability.

Estimated Enrollment: 106
Study Start Date: January 2005
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163488

Locations
United States, California
Altana Pharma/Nycomed
Long Beach, California, United States, 90806
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Mark A. Wingertzahn, Ph.D. Altana Pharma, Florham Park, NJ 07932, USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163488     History of Changes
Other Study ID Numbers: BY9010/M1-409
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Allergy
Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever

Additional relevant MeSH terms:
Fever
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Body Temperature Changes
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Salmeterol
Fluticasone
Ciclesonide
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 29, 2014