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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00305487
First received: March 21, 2006
Last updated: May 4, 2012
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Hay Fever
Seasonal Allergic Rhinitis
Drug: Ciclesonide nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

Secondary Outcome Measures:
  • Physician assessment of nasal symptoms score at endpoint
  • average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
  • safety

Estimated Enrollment: 660
Study Start Date: March 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305487

  Hide Study Locations
Locations
United States, Alabama
Altana Pharma/Nycomed
Birmingham, Alabama, United States, 35235
United States, Arkansas
Altana Pharma/Nycomed
Hot Springs, Arkansas, United States, 71913
United States, California
Altana Pharma/Nycomed
Costa Mesa, California, United States, 92626
Altana Pharma/Nycomed
Huntington Beach, California, United States, 92647
Altana Pharma/Nycomed
Long Beach, California, United States, 90806
Altana Pharma/Nycomed
Los Alamitos, California, United States, 90720
Altana Pharma/Nycomed
Mission Viejo, California, United States, 92691
Altana Pharma/Nycomed
Orange, California, United States, 92868
Altana Pharma/Nycomed
Roseville, California, United States, 95678
Altana Pharma/Nycomed
San Diego, California, United States, 92120
Altana Pharma/Nycomed
San Diego, California, United States, 92123
Altana Pharma/Nycomed
San Jose, California, United States, 95117
Altana Pharma/Nycomed
Stockton, California, United States, 95207
United States, Colorado
Altana Pharma/Nycomed
Colorado Springs, Colorado, United States, 80907
Altana Pharma/Nycomed
Denver, Colorado, United States, 80230
Altana Pharma/Nycomed
Englewood, Colorado, United States, 80112
Altana Pharma/Nycomed
Lakewood, CO, Colorado, United States, 80401
United States, Georgia
Altana Pharma/Nycomed
Atlanta, Georgia, United States, 30342
Altana Pharma/Nycomed
Gainesville, Georgia, United States, 30501
Altana Pharma/Nycomed
Savannah, Georgia, United States, 31406
Altana Pharma/Nycomed
Woodstock, GA, Georgia, United States, 30188
United States, Illinois
Altana Pharma/Nycomed
Normal, Illinois, United States, 61761
United States, Indiana
Altana Pharma/Nycomed
Indianapolis, Indiana, United States, 46208
United States, Kansas
Altana Pharma/Nycomed
Overland Park, Kansas, United States, 66211
United States, Kentucky
Altana Pharma/Nycomed
Louisville, KY, Kentucky, United States, 40215
United States, Louisiana
Altana Pharma/Nycomed
Metairie, Louisiana, United States, 70006
Altana Pharma/Nycomed
Shreveport, Louisiana, United States, 71105
United States, Maryland
Altana Pharma/Nycomed
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Altana Pharma/Nycomed
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Altana Pharma/Nycomed
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Altana Pharma/Nycomed
Jefferson City, Missouri, United States, 65109
Altana Pharma/Nycomed
Rolla, Missouri, United States, 65401
Altana Pharma/Nycomed
St. Louis, Missouri, United States, 63141
United States, Nebraska
Altana Pharma/Nycomed
Lincoln, NE, Nebraska, United States, 68505
Altana Pharma/Nycomed
Papillion, Nebraska, United States, 68046
United States, New Jersey
Altana Pharma/Nycomed
Brick, New Jersey, United States, 08724
Altana Pharma/Nycomed
Forked River, New Jersey, United States, 08731
Altana Pharma/Nycomed
Red Bank, New Jersey, United States, 07701
Altana Pharma/Nycomed
Skillman, New Jersey, United States, 08558
Altana Pharma/Nycomed
Warren, New Jersey, United States, 07059
United States, New York
Altana Pharma/Nycomed
Rochester, NY, New York, United States, 14618
Altana Pharma/Nycomed
Rockville Centre, New York, United States, 11570
United States, North Carolina
Altana Pharma/Nycomed
Raleigh, North Carolina, United States, 27607
United States, Ohio
Altana Pharma/Nycomed
Cincinnati, Ohio, United States, 45219
Altana Pharma/Nycomed
Cincinnati, OH, Ohio, United States, 45231
United States, Oregon
Altana Pharma/Nycomed
Ashland, Oregon, United States, 97520
Altana Pharma/Nycomed
Lake Oswego, Oregon, United States, 97035
Altana Pharma/Nycomed
Medford, OR, Oregon, United States, 97504
Altana Pharma/Nycomed
Portland, Oregon, United States, 97213
United States, Pennsylvania
Altana Pharma/Nycomed
Blue Bell, Pennsylvania, United States, 19422
Altana Pharma/Nycomed
Eerie, Pennsylvania, United States, 16506
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, United States, 15202
Altana Pharma/Nycomed
Pittsburgh, Pennsylvania, United States, 15241
Altana Pharma/Nycomed
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Altana Pharma/Nycomed
Charleston, South Carolina, United States, 29414
Altana Pharma/Nycomed
Charleston, SC, South Carolina, United States, 29407
United States, Tennessee
Altana Pharma/Nycomed
Germantown, Tennessee, United States, 38138
Altana Pharma/Nycomed
Jackson, Tennessee, United States, 38301
United States, Texas
Altana Pharma/Nycomed
Austin, Texas, United States, 78731
Altana Pharma/Nycomed
Austin, Texas, United States, 78750
Altana Pharma/Nycomed
Dallas, Texas, United States, 75231
Altana Pharma/Nycomed
El Paso, Texas, United States, 79925
Altana Pharma/Nycomed
Kerrville, Texas, United States, 78028
Altana Pharma/Nycomed
New Braunfels, Texas, United States, 78130
Altana Pharma/Nycomed
San Antonio, Texas, United States, 78229
United States, Utah
Altana Pharma/Nycomed
Salt Lake City, Utah, United States, 84037
United States, Vermont
Altana Pharma/Nycomed
South Burlington, Vermont, United States, 05403
United States, Virginia
Altana Pharma/Nycomed
Burke, Virginia, United States, 22015
Altana Pharma/Nycomed
Charlottesville, Virginia, United States, 22911
Altana Pharma/Nycomed
Richmond, Virginia, United States, 23226
United States, Wisconsin
Altana Pharma/Nycomed
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Mark A. Wingertzahn, PhD ALTANA Pharma, Florham Park, NJ 07932, USA, info.clintrials@altanapharma.com
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00305487     History of Changes
Other Study ID Numbers: BY9010/M1-417
Study First Received: March 21, 2006
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Hay Fever
Seasonal Allergic Rhinitis
Nasal spray
Ciclesonide
Allergic Rhinitis

Additional relevant MeSH terms:
Fever
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Body Temperature Changes
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014