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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01067105
First received: February 9, 2010
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: ciclesonide HFA 160 μg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Percentage of Subjects Experiencing Adverse Events (AEs) [ Time Frame: Weeks 1-26 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects Experiencing Serious Adverse Events (SAEs) [ Time Frame: Weeks 1-26 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects Who Discontinue Due to AEs. [ Time Frame: Weeks 1-26 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Subjects Experiencing Local Nasal AEs [ Time Frame: Weeks 1-26 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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

    1. = mild
    2. = moderate
    3. = 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 ] [ Designated as safety issue: No ]

    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

    1. = mild
    2. = moderate
    3. = 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 ] [ Designated as safety issue: No ]

    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

    1. = mild
    2. = moderate
    3. = 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 ] [ Designated as safety issue: No ]

    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

    1. = mild
    2. = moderate
    3. = 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.


Enrollment: 824
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ciclesonide
ciclesonide HFA 160 μg once daily
Drug: ciclesonide HFA 160 μg
ciclesonide HFA 160 μg once daily

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01067105

  Show 44 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01067105     History of Changes
Other Study ID Numbers: 060-635
Study First Received: February 9, 2010
Results First Received: February 15, 2012
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Perennial allergic rhinitis
allergic rhinitis
ciclesonide

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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 28, 2014