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

NCT ID: NCT00261287

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hay Fever Perennial Allergic Rhinitis

Keywords

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Hay Fever Allergic Rhinitis Perennial Allergic Rhinitis Ciclesonide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ciclesonide

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

Long Beach, California, United States

Site Status

Altana Pharma/Nycomed

Normal, Illinois, United States

Site Status

Altana Pharma/Nycomed

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BY9010/M1-416

Identifier Type: -

Identifier Source: org_study_id