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

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: ciclesonide HFA 160 μg

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.

• Study Type: Interventional
• Enrollment (Actual): 824
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists Group
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group
    • Mission Viejo, California, United States, 92691
      • Southern California Research
    • Orange, California, United States, 92868
      • CHOC PSF, AMC, Division of Allergy Asthma and Immunology
    • Palmdale, California, United States, 93551
      • California Allergy and Asthma Medical Group
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group
    • Stockton, California, United States, 95207
      • Bensch Research Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
    • Colorado Springs, Colorado, United States, 80907
      • Storms Clinical Research Institute
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Centers
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • DataQuest Medical Research
    • Lilburn, Georgia, United States, 30047
      • Allergy and Asthma Consultants
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
    • Stockbridge, Georgia, United States, 30342
      • Clinical Research Atlanta
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy and Asthma Clinic
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • Clinical Research Center of Indiana
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • GR
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc.
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • Montana
    • Bozeman, Montana, United States, 59718
      • Clinical Research Group of Montana
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Allergy and Asthma Center of NC
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • Toledo Center for Clinical Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Allergy and Ashtma Research Group
    • Lake Oswego, Oregon, United States, 97035
      • Baker Allergy, Asthma, and Dermatology Research Center
    • Portland, Oregon, United States, 977213
      • Allergy Associates Research Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18020
      • Valley Clinical Research
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Asthma, Nasal Disease, and Allergy Research Center of New England
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • National Allergy, Asthma, and Urticaria Centers
  • Texas
    • Austin, Texas, United States, 78731
      • ISIS Clinical Research
    • Austin, Texas, United States, 78759
      • Sirius Clinical Research
    • Boerne, Texas, United States, 78006
      • TTS Research
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research and Consulting
    • Fort Worth, Texas, United States, 76132
      • North Texas Institute for Clinical Trials
    • Houston, Texas, United States, 77054
      • Allergy and Asthma Associates
    • Kerrville, Texas, United States, 78028
      • Kerrville Research Associates
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research
    • San Antonio, Texas, United States, 78229
      • Southwest Allergy and Asthma Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Asthma Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ciclesonide; ciclesonide HFA 160 μg once daily	Drug: ciclesonide HFA 160 μg; ciclesonide HFA 160 μg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Experiencing Local Nasal AEs	Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.	Weeks 1-26
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Weeks 1-26
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Weeks 1-26
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	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.	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Baseline and Months 1, 2, 3, 4, 5, 6
Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances	Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.	Weeks 0-12
Number of Devices With Actuation Consistency	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration	Weeks 0-6 and 6-12
Percentage of Devices With Actuation Consistency	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration	Weeks 0-6 and 6-12
Number of Devices With Major Discrepancies	A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration	Weeks 0-6 and 6-12
Percentage of Devices With Major Discrepancies	A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration	Weeks 0-6 and 6-12
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey	Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.	Weeks 6 and 12

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: allergic rhinitis; Perennial allergic rhinitis; ciclesonide
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: 060-635