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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00384475

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

165.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal Hay Fever	Drug: Ciclesonide Nasal Spray	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mcg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Onset of action, measured by change from baseline in Total Nasal Symptom Score. []

Secondary Outcome Measures

changes in symptoms, safety. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main 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

Main 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