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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis; Hay Fever

• Registration Number: NCT00305487
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Physician assessment of nasal symptoms score at endpoint
safety
average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇺🇸 Milwaukee, Wisconsin, United States