Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Seasonal Allergic Rhinitis

Hay Fever

Treatments

Drug: Ciclesonide nasal spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00305487

BY9010/M1-417

Details and patient eligibility

About

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Written informed consent
General good health other than seasonal allergic rhinitis
Positive standard skin prick test

Main Exclusion Criteria:

Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
Participation in any investigational drug trial within the 30 days preceding the Screening Visit
A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
Use of any prohibited concomitant medications
Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
Study participation by more than one patient from the same household