Status:

COMPLETED

Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

Lead Sponsor:

AstraZeneca

Conditions:

Perennial Allergic Rhinitis

Allergic Rhinitis

Eligibility:

All Genders

6-11 years

Phase:

PHASE3

Brief Summary

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 allergi...

Eligibility Criteria

Inclusion

  • Main
  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick test
  • Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
  • Main

Exclusion

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
  • Use of any prohibited concomitant medications as defined by the study protocol
  • Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

End Date :

July 1 2005

Estimated Enrollment :

636 Patients enrolled

Trial Details

Trial ID

NCT00163514

Start Date

May 1 2004

End Date

July 1 2005

Last Update

December 2 2016

Active Locations (74)

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Page 1 of 19 (74 locations)

1

Altana Pharma/Nycomed

Oxford, Alabama, United States, 36203

2

Altana Pharma/Nycomed

Huntington Beach, California, United States, 92647

3

Altana Pharma/Nycomed

Mission Viejo, California, United States, 92691

4

Altana Pharma/Nycomed

Newport Beach, California, United States, CA 92660