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
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01067105 |
|
Recruitment Status :
Completed
First Posted : February 11, 2010
Results First Posted : June 11, 2012
Last Update Posted : June 13, 2012
|
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perennial Allergic Rhinitis | Drug: ciclesonide HFA 160 μg | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 824 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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 |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | November 2010 |
| Actual Study Completion Date : | November 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ciclesonide
| Arm | Intervention/treatment |
|---|---|
|
Experimental: ciclesonide
ciclesonide HFA 160 μg once daily
|
Drug: ciclesonide HFA 160 μg
ciclesonide HFA 160 μg once daily |
Primary Outcome 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 Outcome 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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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:
- 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.
- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067105
Locations
Show 44 study locations
Sponsors and Collaborators
Sunovion
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT01067105 |
| Other Study ID Numbers: |
060-635 |
| First Posted: | February 11, 2010 Key Record Dates |
| Results First Posted: | June 11, 2012 |
| Last Update Posted: | June 13, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Sunovion:
|
Perennial allergic rhinitis allergic rhinitis ciclesonide |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Ciclesonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |