Allergic Rhinitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age
| 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 | 636 |
| Est. completion date | July 2005 |
| Est. primary completion date | July 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 11 Years |
| Eligibility |
Main Inclusion Criteria: - General good health, other than perennial allergic rhinitis - History and diagnosis of perennial allergic rhinitis by skin prick test - Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.) Main Exclusion Criteria: - Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial - Use of any prohibited concomitant medications as defined by the study protocol - Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Altana Pharma/Nycomed | Hamilton | |
| Canada | Altana Pharma/Nycomed | Hamilton, ON | |
| Canada | Altana Pharma/Nycomed | Kanata, ON | |
| Canada | Altana Pharma/Nycomed | London | |
| Canada | Altana Pharma/Nycomed | London,ON | |
| Canada | Altana Pharma/Nycomed | Mississauga | |
| Canada | Altana Pharma/Nycomed | Montreal, QC | |
| Canada | Altana Pharma/Nycomed | Niagara Falls | |
| Canada | Altana Pharma/Nycomed | Oshawa, ON | |
| Canada | Altana Pharma/Nycomed | Ottawa | |
| Canada | Altana Pharma/Nycomed | Ottawa, ON | |
| Canada | Altana Pharma/Nycomed | Saskatoon,SK | |
| Canada | Altana Pharma/Nycomed | Ste-Foy PQ | |
| Canada | Altana Pharma/Nycomed | Toronto | |
| Canada | Altana Pharma/Nycomed | Toronto, ON | |
| Canada | Altana Pharma/Nycomed | Winnipeg | |
| United States | Altana Pharma/Nycomed | Atlanta | Georgia |
| United States | Altana Pharma/Nycomed | Austin | Texas |
| United States | Altana Pharma/Nycomed | Brick | New Jersey |
| United States | Altana Pharma/Nycomed | Burke | Virginia |
| United States | Altana Pharma/Nycomed | Canton | Ohio |
| United States | Altana Pharma/Nycomed | Charleston | South Carolina |
| United States | Altana Pharma/Nycomed | Charleston | South Carolina |
| United States | Altana Pharma/Nycomed | Cincinnati, OH | Ohio |
| United States | Altana Pharma/Nycomed | Coral Gables | Florida |
| United States | Altana Pharma/Nycomed | Dubuque | Iowa |
| United States | Altana Pharma/Nycomed | Easton | Pennsylvania |
| United States | Altana Pharma/Nycomed | El Paso | Texas |
| United States | Altana Pharma/Nycomed | Fort Worth | Texas |
| United States | Altana Pharma/Nycomed | Friendswood | Texas |
| United States | Altana Pharma/Nycomed | Gainesville | Georgia |
| United States | Altana Pharma/Nycomed | Hershey | Pennsylvania |
| United States | Altana Pharma/Nycomed | Houston | Texas |
| United States | Altana Pharma/Nycomed | Huntington Beach | California |
| United States | Altana Pharma/Nycomed | Indianapolis | Indiana |
| United States | Altana Pharma/Nycomed | Jefferson City | Missouri |
| United States | Altana Pharma/Nycomed | Katy | Texas |
| United States | Altana Pharma/Nycomed | Liverpool | New York |
| United States | Altana Pharma/Nycomed | Medford | Oregon |
| United States | Altana Pharma/Nycomed | Metairie | Louisiana |
| United States | Altana Pharma/Nycomed | Minneapolis | Minnesota |
| United States | Altana Pharma/Nycomed | Mission Viejo | California |
| United States | Altana Pharma/Nycomed | Moncks Corner | South Carolina |
| 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 | Ocala | Florida |
| United States | Altana Pharma/Nycomed | Orange | California |
| United States | Altana Pharma/Nycomed | Overland Park | Kansas |
| United States | Altana Pharma/Nycomed | Oxford | Alabama |
| United States | Altana Pharma/Nycomed | Palmdale | California |
| United States | Altana Pharma/Nycomed | Papillion | Nebraska |
| 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 | Richmond | Virginia |
| United States | Altana Pharma/Nycomed | Rockville | Maryland |
| United States | Altana Pharma/Nycomed | Rolla, Mo | Missouri |
| United States | Altana Pharma/Nycomed | Salt Lake City | Utah |
| United States | Altana Pharma/Nycomed | San Diego | California |
| United States | Altana Pharma/Nycomed | San Diego | California |
| United States | Altana Pharma/Nycomed | San Jose | California |
| United States | Altana Pharma/Nycomed | Savannah | Georgia |
| United States | Altana Pharma/Nycomed | Shreveport | Louisiana |
| United States | Altana Pharma/Nycomed | Skillman | New Jersey |
| United States | Altana Pharma/Nycomed | South Burlington | Vermont |
| United States | Altana Pharma/Nycomed | Spartanburg | South Carolina |
| United States | Altana Pharma/Nycomed | Spokane | Washington |
| United States | Altana Pharma/Nycomed | St. Louis | Missouri |
| United States | Altana Pharma/Nycomed | Stockton | California |
| United States | Altana Pharma/Nycomed | Sylvania | Ohio |
| United States | Altana Pharma/Nycomed | Upland | Pennsylvania |
| United States | Altana Pharma/Nycomed | Walnut Creek, CA | California |
| United States | Altana Pharma/Nycomed | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in Total Nasal Symptom Score | |||
| Secondary | safety, changes in symptoms |
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