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

Last updated: November 29, 2016
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Acute Rhinitis

Allergies & Asthma

Common Cold

Treatment

N/A

Clinical Study ID

NCT00384475
BY9010/M1-413
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 skinprick test

Exclusion

Main Exclusion Criteria:

  • Clinically significant physical finding of nasal anatomical deformities causinggreater than 50% obstruction, including but not limited to nasal polyps, septaldefects, respiratory tract malformations, nasal trauma or surgery

  • Known hypersensitivity to any corticosteroid

  • History of a respiratory infection or disorder including but not limited tobronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratorysyndrome) 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/orroutine use of beta-agonists or any controller drugs

  • Use of antibiotic therapy for acute conditions within 14 days preceding the ScreeningVisit

  • Exposure to systemic corticosteroids for any indication, chronic or intermittentwithin 60 days preceding the Screening Visit

Study Design

Total Participants: 500
Study Start date:
October 01, 2006
Estimated Completion Date:
January 31, 2007

Connect with a study center

  • Altana Pharma/Nycomed

    Ontario, Mississauga, L4W 1N2
    Canada

    Site Not Available

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