Clinical trial NCT01067105: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Keywords: Perennial allergic rhinitis
allergic rhinitis
ciclesonide
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-11
Enrollment: 824
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. 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.
  2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
  3. Abstinence.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Subjects Experiencing Adverse Events (AEs)
timeFrame: Weeks 1-26
measure: Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
timeFrame: Weeks 1-26
measure: Percentage of Subjects Who Discontinue Due to AEs.
timeFrame: Weeks 1-26
Secondary outcomes:
measure: Percentage of Subjects Experiencing Local Nasal AEs
timeFrame: Weeks 1-26
measure: Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
timeFrame: Baseline and Weeks 1-26
measure: Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
timeFrame: Baseline and Weeks 1-26
measure: Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
timeFrame: Baseline and Months 1, 2, 3, 4, 5, and 6
measure: Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
timeFrame: Baseline and Months 1, 2, 3, 4, 5, 6
measure: Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
timeFrame: Weeks 0-12
measure: Number of Devices With Actuation Consistency
timeFrame: Weeks 0-6 and 6-12
measure: Percentage of Devices With Actuation Consistency
timeFrame: Weeks 0-6 and 6-12
measure: Number of Devices With Major Discrepancies
timeFrame: Weeks 0-6 and 6-12
measure: Percentage of Devices With Major Discrepancies
timeFrame: Weeks 0-6 and 6-12
measure: Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
timeFrame: Weeks 6 and 12
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Group
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Orange
country: United States
facility: CHOC PSF, AMC, Division of Allergy Asthma and Immunology
state: California
city: Palmdale
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Lawrenceville
country: United States
facility: DataQuest Medical Research
state: Georgia
city: Lilburn
country: United States
facility: Allergy and Asthma Consultants
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Woodstock
country: United States
facility: Atlanta Allergy and Asthma Clinic
state: Georgia
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: Bethesda
country: United States
facility: GR
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: St. Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: High Point
country: United States
facility: Allergy and Asthma Center of NC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Eugene
country: United States
facility: Allergy and Ashtma Research Group
state: Oregon
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma, and Dermatology Research Center
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Bethlehem
country: United States
facility: Valley Clinical Research
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research
state: Pennsylvania
city: Providence
country: United States
facility: Asthma, Nasal Disease, and Allergy Research Center of New England
state: Rhode Island
city: Charleston
country: United States
facility: National Allergy, Asthma, and Urticaria Centers
state: South Carolina
city: Austin
country: United States
facility: ISIS Clinical Research
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting
state: Texas
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Southwest Allergy and Asthma Center
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research
state: Texas
city: Seattle
country: United States
facility: ASTHMA Inc.
state: Washington
Study officials:
References: