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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00384475
Other study ID # BY9010/M1-413
Secondary ID
Status Completed
Phase Phase 3
First received October 5, 2006
Last updated November 29, 2016
Start date October 2006
Est. completion date January 2007

Study information

Verified date October 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Ciclesonide Nasal Spray


Locations

Country Name City State
Canada Altana Pharma/Nycomed Ontario, Mississauga

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Onset of action, measured by change from baseline in Total Nasal Symptom Score.
Secondary changes in symptoms, safety.
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