Allergic RhinitisPhase 3NCT00953147
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
A Phase 3 study testing Ciclesonide HFA 80 mcg and Ciclesonide HFA 160 mcg in people with Allergic Rhinitis and Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 45 sites in United States.
Trial summary
This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis, Perennial Allergic Rhinitis
- What is being tested?
- Ciclesonide HFA 80 mcg and Ciclesonide HFA 160 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,110 participants
- Where
- 45 sitesUnited States
- Study dates
- Aug 2009to May 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
- Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
- If any of the Screening visit Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
- A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
- A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
- Based upon subject's medical history, in the Investigator's judgment, the subject is unlikely to have a seasonal exacerbation during the first 6 weeks of double-blind treatment.
- Subject, if female ≤65 years of age, must have a negative serum pregnancy test at screening. 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.
Who cannot join
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
- Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
- History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening visit.
Show all 24Show fewer
- History of alcohol or drug abuse within 2 years preceding the Screening visit .
- History of a positive test for HIV, hepatitis B or hepatitis C.
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.
- Expected use of any disallowed concomitant medications during the treatment period.
- Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
- Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
- Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
- Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period.
- Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
- Study participation by more than one subject from the same household.
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial:
- impaired hepatic function including alcohol related liver disease or cirrhosis
- history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts
- any systemic infection
- hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism)
- gastrointestinal disease
- malignancy (excluding basal cell carcinoma)
- current neuropsychological condition with or without drug therapy • Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Clinical Research Atlanta
Atlanta, Georgia, 30342
Allergy and Asthma Associates
Austin, Texas, 78731
Sirius Clinical Research
Austin, Texas, 78759
Gordon D. Raphael, MD
Bethesda, Maryland, 20814
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
Hill Country Family Medical Center
Boerne, Texas, 78006
Clinical Research Group of Montana
Bozeman, Montana, 59718
National Allergy, Asthma, and Urticaria
Charleston, South Carolina, 29406
Asthma and Allergy Associates, P.C.
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
Western Sky Medical Research
El Paso, Texas, 79903
Allergy and Asthma 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
Asthma and Allergy Specialists Medical Group
Huntington Beach, California, 92647
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208
Kerrville Research Associates, PA
Kerrville, Texas, 78028
Kerrville Research Associates
Kerrville, Texas, 78028
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
DataQuest Medical Research, LLC
Lawrenceville, Georgia, 30046
Allergy and Asthma Consultants, PC
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 & Immunology
Orange, California, 92868
California Allerga and Asthma Medical Group
Palmdale, California, 93551
Allergy Associates Research Center
Portland, Oregon, 97213
Asthma, Nasal Disease and Allergy Research Center of New England
Providence, Rhode Island, 02906
North Carolina Clinical Research
Raleigh, North Carolina, 26707
Biogenics Research Institute
San Antonio, Texas, 78229
Southwest Allergy and Asthma Center
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group
San Diego, California, 92120
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
ASTHMA, Inc.
Seattle, Washington, 98105
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Bensch Research Associates
Stockton, California, 95207
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
About this study
Official title: A 6-Month Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).
Read the detailed description
This study will investigate the efficacy and safety of once daily ciclesonide HFA Nasal Aerosol for 26 weeks. The primary objective is to evaluate the efficacy of ciclesonide HFA (80 mcg and 160 mcg) over 6 weeks, compared to placebo in subjects with PAR. Secondary objectives are to evaluate safety and tolerability and quality of life after treatment with ciclesonide HFA (80 mcg and 160 mcg), over 6 weeks and over 6 months.
The study will consist of a Screening period (7 to 21 (±3) days) from Visit 1 to Visit 2, followed by a Single-blind Placebo Run-in period (7 to 10 days) from Visit 2 to Visit 3, followed by a 6-month (26 weeks) double-blind treatment period (Visit 3 through Visit 11). Subjects who complete this study will be allowed to participate in a 6-month open-label extension study (Study 060-635).
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
- Allergic Rhinitis, Perennial Allergic Rhinitis
- Being tested
- Ciclesonide HFA 80 mcg, Ciclesonide HFA 160 mcg, Placebo
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide HFA 80 mcgDrug
Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
Ciclesonide HFA 160 mcgDrug
Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
PlaceboDrug
Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide HFA 80 mcg once daily | Experimental | Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day). Receives: Drug: Ciclesonide HFA 80 mcg |
| Ciclesonide HFA 160 mcg once daily | Experimental | Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day). Receives: Drug: Ciclesonide HFA 160 mcg |
| Placebo once daily | Placebo comparator | The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Secondary outcomes (13)
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
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 week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
NSS is the assessment of the 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 Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0 - 6
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
NSS is the assessment of the 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 Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
NSS is the assessment of the 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 Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
NSS is the assessment of the 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
NSS is the assessment of the 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
NSS is the assessment of the 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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0-6
Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0
RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.
Measured: Baseline and Week 6
Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,110 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
- NCT00953147
- Sponsor's protocol ID
- 060-633
- Status last verified
- Jun 2012
- First submitted
- 4 Aug 2009
- Last updated
- 13 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.
PubMed 22370530
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 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
- ClinicalTrials.gov ID
- NCT00953147
- Acronym / sponsor ID
- 060-633
- Conditions
- Allergic Rhinitis, Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 7 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).
Detailed description
This study will investigate the efficacy and safety of once daily ciclesonide HFA Nasal Aerosol for 26 weeks. The primary objective is to evaluate the efficacy of ciclesonide HFA (80 mcg and 160 mcg) over 6 weeks, compared to placebo in subjects with PAR. Secondary objectives are to evaluate safety and tolerability and quality of life after treatment with ciclesonide HFA (80 mcg and 160 mcg), over 6 weeks and over 6 months.
The study will consist of a Screening period (7 to 21 (±3) days) from Visit 1 to Visit 2, followed by a Single-blind Placebo Run-in period (7 to 10 days) from Visit 2 to Visit 3, followed by a 6-month (26 weeks) double-blind treatment period (Visit 3 through Visit 11). Subjects who complete this study will be allowed to participate in a 6-month open-label extension study (Study 060-635).
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide HFA 80 mcg once daily | Experimental | Drug: Ciclesonide HFA 80 mcgCiclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day). |
| Ciclesonide HFA 160 mcg once daily | Experimental | Drug: Ciclesonide HFA 160 mcgCiclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day). |
| Placebo once daily | Placebo comparator | Drug: PlaceboThe placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
- If any of the Screening visit Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
- A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and require treatment throughout the entire study period.
- A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
Key exclusion criteria (24 listed)
- Female subject who is pregnant or lactating.
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
- Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
- Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
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 80 mcgCiclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older. | Drug | Ciclesonide HFA 80 mcg once daily |
| Ciclesonide HFA 160 mcgCiclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older. | Drug | Ciclesonide HFA 160 mcg once daily |
| PlaceboPlacebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older. | Drug | Placebo once daily |
Primary outcome
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
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 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 six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
13 secondary outcomes
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Time frame: Weeks 0 - 6
Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Time frame: Weeks 0-6
Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Time frame: Weeks 0-6
Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0
Time frame: Baseline and Week 6
Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
Time frame: Baseline and Week 26
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.
- Results publication: PubMed 22370530Mohar D, Berger WE, Laforce C, Raphael G, Desai SY, Huang H, Hinkle J. Efficacy and tolerability study of ciclesonide nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2012 Jan-Feb;33(1):19-26. doi: 10.2500/aap.2012.33.3522.
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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.
45 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 80 mcg and Ciclesonide HFA 160 mcg in people with Allergic Rhinitis and Perennial Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 45 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 7 inclusion and 24 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 45 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. Some participants in this study may receive a placebo. 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 7 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?
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment (time frame: Weeks 0-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953147, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 7 Nov 2026.