Perennial Allergic RhinitisPhase 3NCT01067105
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 Phase 3 study testing ciclesonide HFA 160 μg in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- ciclesonide HFA 160 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 44 sitesUnited States
- Study dates
- Feb 2010to Nov 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
ISIS Clinical Research
Austin, Texas, 78731
Sirius Clinical Research
Austin, Texas, 78759
GR
Bethesda, Maryland, 20814
Valley Clinical Research
Bethlehem, Pennsylvania, 18020
TTS Research
Boerne, Texas, 78006
Clinical Research Group of Montana
Bozeman, Montana, 59718
National Allergy, Asthma, and Urticaria Centers
Charleston, South Carolina, 29406
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
Pharmaceutical Research and Consulting
Dallas, Texas, 75231
Colorado Allergy and Asthma Centers
Denver, Colorado, 80230
Allergy and Ashtma Research Group
Eugene, Oregon, 97401
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132
Allergy and Asthma Center of NC
High Point, North Carolina, 27262
Allergy and Asthma Associates
Houston, Texas, 77054
Allergy and Asthma Specialists Group
Huntington Beach, California, 92647
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208
Kerrville Research Associates
Kerrville, Texas, 78028
Baker Allergy, Asthma, and Dermatology Research Center
Lake Oswego, Oregon, 97035
DataQuest Medical Research
Lawrenceville, Georgia, 30046
Allergy and Asthma Consultants
Lilburn, Georgia, 30047
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Southern California Research
Mission Viejo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
CHOC PSF, AMC, Division of Allergy Asthma and Immunology
Orange, California, 92868
California Allergy and Asthma Medical Group
Palmdale, California, 93551
Western Sky Medical Research
Paso, Texas, 79903
Allergy Associates Research Center
Portland, Oregon, 977213
Asthma, Nasal Disease, and Allergy Research Center of New England
Providence, Rhode Island, 02906
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Biogenics Research Institute
San Antonio, Texas, 78229
Southwest Allergy and Asthma Center
San Antonio, Texas, 78229
Sylvana Research
San Antonio, Texas, 78229
Allergy Associates Medical Group
San Diego, California, 92120
ASTHMA Inc.
Seattle, Washington, 98105
The Clinical Research Center
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Clinical Research Atlanta
Stockbridge, Georgia, 30342
Bensch Research Associates
Stockton, California, 95207
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Asthma and Allergy Research
Upland, Pennsylvania, 19013
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, 30188
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
About this study
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
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.
Read the 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.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- ciclesonide HFA 160 μg
- Keywords
- Perennial allergic rhinitis, allergic rhinitis, ciclesonide
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclesonide HFA 160 μgDrug
ciclesonide HFA 160 μg once daily
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide | Experimental | ciclesonide HFA 160 μg once daily Receives: Drug: ciclesonide HFA 160 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Experiencing Adverse Events (AEs)
Measured: Weeks 1-26
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Measured: Weeks 1-26
Percentage of Subjects Who Discontinue Due to AEs.
Measured: Weeks 1-26
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067105
- Sponsor's protocol ID
- 060-635
- Status last verified
- Jun 2012
- First submitted
- 9 Feb 2010
- Last updated
- 13 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01067105
- Acronym / sponsor ID
- 060-635
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- Perennial allergic rhinitis, allergic rhinitis, ciclesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Feb 2010 (estimated)
- Results
- Posted 11 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ciclesonide | Experimental | Drug: ciclesonide HFA 160 μgciclesonide HFA 160 μg once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciclesonide HFA 160 μgciclesonide HFA 160 μg once daily | Drug | ciclesonide |
Primary outcome
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
11 secondary outcomes
Percentage of Subjects Experiencing Local Nasal AEs
Time frame: Weeks 1-26
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
Time frame: Baseline and Weeks 1-26
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
Time frame: Baseline and Weeks 1-26
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
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
Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
Time frame: Weeks 0-12
Number of Devices With Actuation Consistency
Time frame: Weeks 0-6 and 6-12
Percentage of Devices With Actuation Consistency
Time frame: Weeks 0-6 and 6-12
Number of Devices With Major Discrepancies
Time frame: Weeks 0-6 and 6-12
Percentage of Devices With Major Discrepancies
Time frame: Weeks 0-6 and 6-12
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
Time frame: Weeks 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciclesonide HFA 160 μg in people with Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Experiencing Adverse Events (AEs) (time frame: Weeks 1-26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.