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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Perennial Allergic Rhinitis

Allergic Rhinitis

Hay Fever

Treatments

Drug: Ciclesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163514

BY9010/M1-403

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

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 Criteria:

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