Back to resultsA Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
Primary Purpose
Rhinitis, Allergic, Seasonal, Hay Fever
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ciclesonide Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR
Eligibility Criteria
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
Sites / Locations
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
Onset of action, measured by change from baseline in Total Nasal Symptom Score.
Secondary Outcome Measures
changes in symptoms, safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00384475
Brief Title
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Hay Fever
Keywords
Seasonal Allergic Rhinitis, Ciclesonide, Hay Fever, SAR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide Nasal Spray
Primary Outcome Measure Information:
Title
Onset of action, measured by change from baseline in Total Nasal Symptom Score.
Secondary Outcome Measure Information:
Title
changes in symptoms, safety.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Ontario, Mississauga
ZIP/Postal Code
L4W 1N2
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4538&filename=BY9010-M1-413-RDS-2007-06-05.pdf
Description
BY9010-M1-413-RDS-2007-06-05.pdf
Learn more about this trial
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
We'll reach out to this number within 24 hrs