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

NCT00384475 | Completed Phase 3

• 1 other identifier: BY9010/M1-413
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Seasonal; Hay Fever

Keywords

Seasonal Allergic Rhinitis; Ciclesonide; Hay Fever; SAR

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• changes in symptoms, safety.

Interventions

Ciclesonide Nasal Spray DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Altana Pharma/Nycomed

Ontario, Mississauga, L4W 1N2, Canada

Location

Related Links

• BY9010-M1-413-RDS-2007-06-05.pdf

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2006
• First Posted: October 6, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 30, 2016

Record last verified: 2016-10

Locations

CA (1)