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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis; Hay Fever

Treatments: Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261287

BY9010/M1-416

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

Sex: All

Ages: 2 to 5 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
• History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

• Participation in any investigational drug trial within the 30 days before the screening visit
• Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
• A known hypersensitivity to any corticosteroid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind