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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00384475 |
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Date of registration:
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05/10/2006 |
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Primary sponsor: |
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Public title:
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A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
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Scientific title:
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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 |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00384475 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Peter Couroux, MD, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allied Research International, Mississauga, ON L4W 1N2, Canada |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hay Fever
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Rhinitis, Allergic, Seasonal
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Intervention(s)
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Drug: Ciclesonide Nasal Spray
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Primary Outcome(s)
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Onset of action, measured by change from baseline in Total Nasal Symptom Score.
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Secondary Outcome(s)
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changes in symptoms, safety.
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Secondary ID(s)
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BY9010/M1-413
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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