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NCT00305487 Clinical Trial

Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00305487
Other study ID # BY9010/M1-417
Secondary ID
Status Completed
Phase Phase 3
First received March 21, 2006
Last updated November 29, 2016
Start date March 2006
Est. completion date October 2006

Study information
Verified date October 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Recruitment information / eligibility
Status Completed
Enrollment 660
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility Main Inclusion Criteria:

- Written informed consent

- General good health other than seasonal allergic rhinitis

- Positive standard skin prick test

Main Exclusion Criteria:

- Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization

- Participation in any investigational drug trial within the 30 days preceding the Screening Visit

- A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation

- Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period

- Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period

- Use of any prohibited concomitant medications

- Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit

- Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit

- Study participation by more than one patient from the same household

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Ciclesonide nasal spray

Locations
Country Name City State
United States Altana Pharma/Nycomed Ashland Oregon
United States Altana Pharma/Nycomed Atlanta Georgia
United States Altana Pharma/Nycomed Austin Texas
United States Altana Pharma/Nycomed Austin Texas
United States Altana Pharma/Nycomed Bethesda Maryland
United States Altana Pharma/Nycomed Birmingham Alabama
United States Altana Pharma/Nycomed Blue Bell Pennsylvania
United States Altana Pharma/Nycomed Brick New Jersey
United States Altana Pharma/Nycomed Burke Virginia
United States Altana Pharma/Nycomed Charleston South Carolina
United States Altana Pharma/Nycomed Charleston, SC South Carolina
United States Altana Pharma/Nycomed Charlottesville Virginia
United States Altana Pharma/Nycomed Cincinnati Ohio
United States Altana Pharma/Nycomed Cincinnati, OH Ohio
United States Altana Pharma/Nycomed Colorado Springs Colorado
United States Altana Pharma/Nycomed Costa Mesa California
United States Altana Pharma/Nycomed Dallas Texas
United States Altana Pharma/Nycomed Denver Colorado
United States Altana Pharma/Nycomed Eerie Pennsylvania
United States Altana Pharma/Nycomed El Paso Texas
United States Altana Pharma/Nycomed Englewood Colorado
United States Altana Pharma/Nycomed Forked River New Jersey
United States Altana Pharma/Nycomed Gainesville Georgia
United States Altana Pharma/Nycomed Germantown Tennessee
United States Altana Pharma/Nycomed Hot Springs Arkansas
United States Altana Pharma/Nycomed Huntington Beach California
United States Altana Pharma/Nycomed Indianapolis Indiana
United States Altana Pharma/Nycomed Jackson Tennessee
United States Altana Pharma/Nycomed Jefferson City Missouri
United States Altana Pharma/Nycomed Kerrville Texas
United States Altana Pharma/Nycomed Lake Oswego Oregon
United States Altana Pharma/Nycomed Lakewood, CO Colorado
United States Altana Pharma/Nycomed Lincoln, NE Nebraska
United States Altana Pharma/Nycomed Long Beach California
United States Altana Pharma/Nycomed Los Alamitos California
United States Altana Pharma/Nycomed Louisville, KY Kentucky
United States Altana Pharma/Nycomed Medford, OR Oregon
United States Altana Pharma/Nycomed Metairie Louisiana
United States Altana Pharma/Nycomed Milwaukee Wisconsin
United States Altana Pharma/Nycomed Minneapolis Minnesota
United States Altana Pharma/Nycomed Mission Viejo California
United States Altana Pharma/Nycomed New Braunfels Texas
United States Altana Pharma/Nycomed Normal Illinois
United States Altana Pharma/Nycomed North Dartmouth Massachusetts
United States Altana Pharma/Nycomed Orange California
United States Altana Pharma/Nycomed Overland Park Kansas
United States Altana Pharma/Nycomed Papillion Nebraska
United States Altana Pharma/Nycomed Pittsburgh Pennsylvania
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 Red Bank New Jersey
United States Altana Pharma/Nycomed Richmond Virginia
United States Altana Pharma/Nycomed Rochester, NY New York
United States Altana Pharma/Nycomed Rockville Centre New York
United States Altana Pharma/Nycomed Rolla Missouri
United States Altana Pharma/Nycomed Roseville California
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 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 St. Louis Missouri
United States Altana Pharma/Nycomed Stockton California
United States Altana Pharma/Nycomed Upland Pennsylvania
United States Altana Pharma/Nycomed Warren New Jersey
United States Altana Pharma/Nycomed Woodstock, GA Georgia

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary Physician assessment of nasal symptoms score at endpoint
Secondary average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
Secondary safety
See also
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Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
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Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
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Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A

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