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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

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.

Interventions

  • Drug: ciclesonide HFA 160 μg
    • ciclesonide HFA 160 μg once daily

Arms, Groups and Cohorts

  • Experimental: ciclesonide
    • ciclesonide HFA 160 μg once daily

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Subjects Experiencing Adverse Events (AEs)
    • Time Frame: Weeks 1-26
  • Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
    • Time Frame: Weeks 1-26
  • Percentage of Subjects Who Discontinue Due to AEs.
    • Time Frame: Weeks 1-26

Secondary Measures

  • Percentage of Subjects Experiencing Local Nasal AEs
    • Time Frame: Weeks 1-26
    • 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.
  • Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
    • Time Frame: Baseline and Weeks 1-26
    • 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.
  • Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
    • Time Frame: Baseline and Weeks 1-26
    • 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.
  • Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
    • Time Frame: Baseline and Months 1, 2, 3, 4, 5, and 6
    • 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.
  • Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
    • Time Frame: Baseline and Months 1, 2, 3, 4, 5, 6
    • 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.
  • Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
    • Time Frame: Weeks 0-12
    • Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.
  • Number of Devices With Actuation Consistency
    • Time Frame: Weeks 0-6 and 6-12
    • Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
  • Percentage of Devices With Actuation Consistency
    • Time Frame: Weeks 0-6 and 6-12
    • Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
  • Number of Devices With Major Discrepancies
    • Time Frame: Weeks 0-6 and 6-12
    • A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration
  • Percentage of Devices With Major Discrepancies
    • Time Frame: Weeks 0-6 and 6-12
    • A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration
  • Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
    • Time Frame: Weeks 6 and 12
    • Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunovion
  • Provider of Information About this Clinical Study
    • Sponsor

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