Safety and Tolerability of Ciclesonide Nasal Spray in Patients with Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

Study identifier:BY9010/M1-416

ClinicalTrials.gov identifier:NCT00261287

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

Medical condition

Hay Fever

Phase

Phase 3

Healthy volunteers

No

Study drug

Ciclesonide

Sex

All

Actual Enrollment

102

Study type

Interventional

Age

2 Years - 5 Years

Date

Study Start Date: 01 Nov 2005
Primary Completion Date: 01 Jun 2006
Study Completion Date: 01 Jun 2006

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria