A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
1 other identifier
interventional
824
1 country
44
Brief Summary
6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2010
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
June 11, 2012
CompletedJune 13, 2012
June 1, 2012
9 months
February 9, 2010
February 15, 2012
June 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Subjects Experiencing Adverse Events (AEs)
Weeks 1-26
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Weeks 1-26
Percentage of Subjects Who Discontinue Due to AEs.
Weeks 1-26
Secondary Outcomes (11)
Percentage of Subjects Experiencing Local Nasal AEs
Weeks 1-26
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
Baseline and Weeks 1-26
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
Baseline and Weeks 1-26
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
Baseline and Months 1, 2, 3, 4, 5, and 6
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
Baseline and Months 1, 2, 3, 4, 5, 6
- +6 more secondary outcomes
Study Arms (1)
ciclesonide
EXPERIMENTALciclesonide HFA 160 μg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Subject has successfully completed all visits of Study 060-633.
- Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject is male or female 12 years and older.
- Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.
- Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- Abstinence.
You may not qualify if:
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps.
- Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Allergy and Asthma Specialists Group
Huntington Beach, California, 92647, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
Southern California Research
Mission Viejo, California, 92691, United States
CHOC PSF, AMC, Division of Allergy Asthma and Immunology
Orange, California, 92868, United States
California Allergy and Asthma Medical Group
Palmdale, California, 93551, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Bensch Research Associates
Stockton, California, 95207, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230, United States
DataQuest Medical Research
Lawrenceville, Georgia, 30046, United States
Allergy and Asthma Consultants
Lilburn, Georgia, 30047, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30342, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188, United States
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208, United States
GR
Bethesda, Maryland, 20814, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
Allergy and Asthma Center of NC
High Point, North Carolina, 27262, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
Allergy and Ashtma Research Group
Eugene, Oregon, 97401, United States
Baker Allergy, Asthma, and Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
Allergy Associates Research Center
Portland, Oregon, 977213, United States
Valley Clinical Research
Bethlehem, Pennsylvania, 18020, United States
Asthma and Allergy Research
Upland, Pennsylvania, 19013, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
Providence, Rhode Island, 02906, United States
National Allergy, Asthma, and Urticaria Centers
Charleston, South Carolina, 29406, United States
ISIS Clinical Research
Austin, Texas, 78731, United States
Sirius Clinical Research
Austin, Texas, 78759, United States
TTS Research
Boerne, Texas, 78006, United States
Pharmaceutical Research and Consulting
Dallas, Texas, 75231, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132, United States
Allergy and Asthma Associates
Houston, Texas, 77054, United States
Kerrville Research Associates
Kerrville, Texas, 78028, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Western Sky Medical Research
Paso, Texas, 79903, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Southwest Allergy and Asthma Center
San Antonio, Texas, 78229, United States
Sylvana Research
San Antonio, Texas, 78229, United States
ASTHMA Inc.
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Open label study investigating a dose higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 mcg is equivalent to 160 mcg.
Results Point of Contact
- Title
- Respiratory Medical Director
- Organization
- Sunovion
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 11, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 13, 2012
Results First Posted
June 11, 2012
Record last verified: 2012-06