Allergic Rhinitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
| Verified date | October 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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 perennial allergic rhinitis.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Main Inclusion Criteria: - General good health, other than perennial allergic rhinitis - History and diagnosis of perennial allergic rhinitis by skin prick test Main Exclusion Criteria: - Participation in any investigational drug trial within the 30 days preceding the Screening Visit - A known hypersensitivity to any corticosteroid or any of the excipients in the formulation - Use of any prohibited concomitant medications as defined by the study protocol |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Altana Pharma/Nycomed | Atlanta | Georgia |
| United States | Altana Pharma/Nycomed | Austin | Texas |
| United States | Altana Pharma/Nycomed | Bethesda | Maryland |
| United States | Altana Pharma/Nycomed | Cincinnati | Ohio |
| United States | Altana Pharma/Nycomed | Cincinnati | Ohio |
| United States | Altana Pharma/Nycomed | Clearwater | Florida |
| United States | Altana Pharma/Nycomed | Cranston | Rhode Island |
| United States | Altana Pharma/Nycomed | Dallas | Texas |
| United States | Altana Pharma/Nycomed | Deland | Florida |
| United States | Altana Pharma/Nycomed | Easton | Pennsylvania |
| United States | Altana Pharma/Nycomed | Encinitas | California |
| United States | Altana Pharma/Nycomed | Forked River | New Jersey |
| United States | Altana Pharma/Nycomed | Houston | Texas |
| United States | Altana Pharma/Nycomed | Huntington Beach | California |
| United States | Altana Pharma/Nycomed | Kerrville | Texas |
| United States | Altana Pharma/Nycomed | Liverpool | New York |
| United States | Altana Pharma/Nycomed | Long Beach | California |
| United States | Altana Pharma/Nycomed | Los Angeles | California |
| United States | Altana Pharma/Nycomed | Milwaukee | Wisconsin |
| United States | Altana Pharma/Nycomed | Mission Viejo | California |
| United States | Altana Pharma/Nycomed | New Braunfels | Texas |
| United States | Altana Pharma/Nycomed | New Orleans | Louisiana |
| United States | Altana Pharma/Nycomed | Newport Beach | California |
| United States | Altana Pharma/Nycomed | Normal | Illinois |
| United States | Altana Pharma/Nycomed | North Dartmouth | Massachusetts |
| United States | Altana Pharma/Nycomed | Oklahoma | Oklahoma |
| United States | Altana Pharma/Nycomed | Overland Park | Kansas |
| United States | Altana Pharma/Nycomed | Pittsburgh | Pennsylvania |
| United States | Altana Pharma/Nycomed | Portland | Oregon |
| United States | Altana Pharma/Nycomed | Raleigh | North Carolina |
| United States | Altana Pharma/Nycomed | Richmond | Virginia |
| United States | Altana Pharma/Nycomed | Salt Lake City | Utah |
| United States | Altana Pharma/Nycomed | San Antonio | Texas |
| United States | Altana Pharma/Nycomed | San Diego | California |
| United States | Altana Pharma/Nycomed | San Diego | California |
| United States | Altana Pharma/Nycomed | Skillman | New Jersey |
| United States | Altana Pharma/Nycomed | Springfield | New Jersey |
| United States | Altana Pharma/Nycomed | Stockton | California |
| United States | Altana Pharma/Nycomed | Trumbull | Connecticut |
| United States | Altana Pharma/Nycomed | Vista | California |
| United States | Altana Pharma/Nycomed | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in Total Nasal Symptom Scores. | |||
| Secondary | change in symptoms, quality of life, safety. |
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