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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciclesonide | Experimental | ciclesonide HFA 160 μg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciclesonide HFA 160 μg | Drug | ciclesonide HFA 160 μg once daily |
|
| Measure | Description | 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 |
| 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. |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy and Asthma Specialists Group | Huntington Beach | California | 92647 | United States | ||
| California Allergy and Asthma Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciclesonide | ciclesonide HFA 160 μg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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
|
| 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
| 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
| 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
| 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 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciclesonide | ciclesonide HFA 160 μg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity | Number | participants |
| |||||||||||||||||||||||
| Baseline AM Reflective Total Nasal Symptom Score (rTNSS) | 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
| Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Baseline AM Instantaneous Total Nasal Symptom Score (iTNSS) | 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
| Median | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Experiencing Adverse Events (AEs) | Intent to Treat Population | Posted | Number | percentage of participants | Weeks 1-26 |
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| Primary | Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | Intent to Treat Population | Posted | Number | percentage of participants | Weeks 1-26 |
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| |||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Discontinue Due to AEs. | Intent to Treat Population | Posted | Number | percentage of participants | Weeks 1-26 |
|
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| |||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat Population | Posted | Number | percentage of participants | Weeks 1-26 |
|
| |||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat Population. Subjects with missing date were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 1-26 |
|
| ||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat Population. Subjects with missing date were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 1-26 |
|
| ||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat Population. Subjects with missing date were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Months 1, 2, 3, 4, 5, and 6 |
|
| ||||||||||||||||||||||||||
| Secondary | 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
| Intent to Treat Population. Subjects with missing date were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Months 1, 2, 3, 4, 5, 6 |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses. | Posted | Mean | Standard Deviation | percentage of correct advances | Weeks 0-12 |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | Intent to Treat Population. | Posted | Number | devices | Weeks 0-6 and 6-12 |
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| |||||||||||||||||||||||||||
| Secondary | 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 | Intent to Treat Population | Posted | Number | percentage of devices | Weeks 0-6 and 6-12 |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Intent to Treat Population | Posted | Number | devices | Weeks 0-6 and 6-12 |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Intent to Treat Population | Posted | Number | percentage of devices | Weeks 0-6 and 6-12 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Intent to Treat Population | Posted | Number | participants | Weeks 6 and 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciclesonide | ciclesonide HFA 160 μg once daily | 15 | 824 | 329 | 824 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Artrial flutter | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Renal injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Troponin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Mental status change | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Imprisonment | Social circumstances | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Urinary tract infection | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion | 1-866-503-6351 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Unknown or Not Reported |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Multiple |
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| Week 6-12 |
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| Week 6-12 |
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| Title | Denominators | Categories |
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| Week 6-12 |
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| Week 6-12 |
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| Title | Denominators | Categories |
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| Week 12 |
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