A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.

Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal Hay Fever

Keywords

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Seasonal Allergic Rhinitis Ciclesonide Hay Fever SAR

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 Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* General good health
* History of SAR to short ragweed pollen for 2 years immediately preceding the study
* Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test

Exclusion Criteria

* Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery
* Known hypersensitivity to any corticosteroid
* History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit
* History of alcohol or drug abuse within 2 years preceding the Screening Visit
* Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs
* Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit
* Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Ontario, Mississauga, , Canada

Site Status

Countries

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Canada

Other Identifiers

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BY9010/M1-413

Identifier Type: -

Identifier Source: org_study_id