Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163501
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • change in Total Nasal Symptom Scores.

Secondary Outcome Measures:
  • change in symptoms, quality of life, safety.

Estimated Enrollment: 600
Study Start Date: December 2003
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   12 Years and older
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 test

Main Exclusion Criteria:

  • 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 formulation
  • Use of any prohibited concomitant medications as defined by the study protocol
  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: NCT00163501

  Show 41 Study Locations
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: NCT00163501     History of Changes
Other Study ID Numbers: BY9010/M1-404
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
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014