Perennial Allergic RhinitisPhase 3NCT01451541
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
A Phase 3 study testing Ciclesonide nasal aerosol 37 mcg and ciclesonide nasal aerosol 74 mcg in people with Perennial Allergic Rhinitis and PAR, run by Sumitomo Pharma America, Inc. at 60 sites in United States.
Trial summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Perennial Allergic Rhinitis, PAR
- What is being tested?
- Ciclesonide nasal aerosol 37 mcg and ciclesonide nasal aerosol 74 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- 60 sitesUnited States
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 3
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gives written informed consent (parent/legal guardian) and assent (from the child), including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
- Is a male or premenarchal female 6 to 11 years old at the screening visit.
- Is in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination and medical history.
- Has a history of PAR to a relevant perennial allergen (house dust mites, cockroaches, molds, and animal dander) for a minimum of 1 year 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.
- Has a demonstrated sensitivity to at least 1 allergen known to induce PAR (house dust mites, cockroaches, molds, and animal dander) based on a documented result with a standard skin-prick test either within 12 months prior to screening visit or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR, and the allergen must be present in the subject's environment throughout the study.
- Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and PRQLQ
Who cannot join
- Has a history of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent unhealed nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the 120 days prior to the screening visit.
- Has evidence of infection, significant anatomic abnormality, ulceration of the mucosa, blood in the nose, or any other clinically relevant finding on nasal examination at the screening visit.
- Has nasal jewelry.
- Has participated in any investigational drug trial within the 30 days preceding the screening visit or is planning participation in another investigational drug trial at any time during this trial.
- Has a known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
- Has a history of a respiratory infection or disorder, including but not limited to bronchitis, pneumonia, influenza, and severe acute respiratory syndrome, within the 14 days preceding the screening visit.
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- Has active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists); intermittent use (≤ 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.
- Is expecting to use any disallowed concomitant medications during the treatment period.
- Is, in the investigator's judgment, having a seasonal exacerbation at the time of the screening visit or is likely to have one during the study.
- Is planning 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.
- Has nonvaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the screening visit.
- Initiates pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or plans a dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
- Is a child or relative of any clinical investigator or site personnel, even those who are not directly involved in this study.
- Resides in the same household as another subject who is participating in this study.
- Has any of the following conditions that are judged by the investigator to be clinically significant and/or to affect the subject's ability to participate in the clinical trial:
- impaired hepatic function
- history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts or herpes simplex
- any systemic infection
- hematological (including anemia), hepatic, renal, endocrine disease
- gastrointestinal disease
- malignancy (excluding basal cell carcinoma)
- current neuropsychological condition with or without drug therapy. Any behavioral condition that could affect the subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism.
- Has any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with the capture of the assessments as written.
- Has received ciclesonide nasal aerosol in a previous clinical trial.
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Isis Clinical Research LLC
Austin, Texas, 78731
Sirius Clinical Research
Austin, Texas, 787
The Asthma and Allergy Center, PC
Bellevue, Nebraska, 68123
Gordon Raphael, MD
Bethesda, Maryland, 20814
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
TTS Research
Boerne, Texas, 78006
Boys Town National Research Hospital
Boys Town, Nebraska, 68010
Clinical Research Group of Montana
Bozeman, Montana, 59718
PI-Coor Clinical Research
Burke, Virginia, 22015
Colorado Allergy and Asthma Centers, PC
Centennial, Colorado, 80112
IMMUNOe International Research Centers
Centennial, Colorado, 80112
Sterling Research Group Ltd
Cincinnati, Ohio, 45246
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
West Coast Clinical Trials, LLC
Costa Mesa, California, 92626
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231
Premier Health Research Center
Downey, California, 90241
Western Sky Medical Research
El Paso, Texas, 79903
Catalyst Medical Center
Fargo, North Dakota, 58103
Cyn3rgy Research
Gresham, Oregon, 97030
Clinical Research Partners, LLC
Henrico, Virginia, 23233
Allergy and Asthma Center of NC, PA
High Point, North Carolina, 27262
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, 92647
Pediatric Care Medical Group
Huntington Beach, California, 92647
Kerrville Research Associates
Kerrville, Texas, 78028
Baker Allergy Asthma and Dermatolgy Research Center, LLC
Lake Oswego, Oregon, 97035
DataQuest Medical Research, LLC
Lawerenceville, Georgia, 30045
College Park Family Care Center
Lenexa, Kansas, 66215
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Allergy and Asthma Assoc of Southern CA
Mission Veijo, California, 92691
Central Texas Health Research
New Braunfels, Texas, 78130
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
National Allergy, Ashtma, and Urticaria Centers of Charleston, PA
North Charleston, South Carolina, 29406
Northeast Medical Research Associates Inc
North Dartmouth, Massachusetts, 02747
Atlantic Research Center LLC
Ocean City, New Jersey, 07712
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Amy Darter, MD
Oklahoma City, Oklahoma, 73131
Center for Clinical Trials, LLC
Paramount, California, 90723
Clinical Research Institute Inc
Plymouth, Minnesota, 55441
Allergy Associates Research Center
Portland, Oregon, 97202
Ashtma and Allergy Associates
Pueblo, Colorado, 81001
Island Medical Research P.C.
Rockville Centre, New York, 11570
J. Lewis Research Inc.
Salt Lake City, Utah, 84109
J. Lewis Research Inc.
Salt Lake City, Utah, 84121
Sylvana Research Associates
San Antonio, Texas, 78229
Allergy Associates Medical Group
San Diego, California, 92120
Allergy and Asthma Medical Group & Research Center
San Diego, California, 92123
Sansum Clinic
Santa Barbara, California, 93110
Aeroallergy Research Labs of Savannah
Savannah, Georgia, 31406
ASTHMA, Inc.
Seattle, Washington, 98105
J. Lewis Research Inc.
South Jordan, Utah, 84095
Atlanta Allergy and Asthma Clinic
Stockbridge, Georgia, 30281
Clinical Research Atlanta
Stockton, Georgia, 30281
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013
Allergy and Asthma Research Institute
Waco, Texas, 76712
Clinical Research of the Ozarks
Warrensburg, Missouri, 64093
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
About this study
Official title: A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
Read the detailed description
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. This study will consist of the following periods/visits: Screening , Single-blind Placebo Run-in period, Double-blind Treatment period , Follow-up. The total duration of subject participation will be approximately 5 months.
- Conditions
- Perennial Allergic Rhinitis, PAR
- Being tested
- Ciclesonide nasal aerosol 37 mcg, ciclesonide nasal aerosol 74 mcg, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide nasal aerosol 37 mcgDrug
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37
ciclesonide nasal aerosol 74 mcgDrug
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
PlaceboDrug
Placebo - one dose per nostril
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide nasal aerosol 37mcg | Active comparator | ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily Receives: Drug: Ciclesonide nasal aerosol 37 mcg |
| ciclesonide nasal aerosol 74 mcg | Active comparator | ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily Receives: Drug: ciclesonide nasal aerosol 74 mcg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the 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 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.
Measured: Weeks 0-6
Secondary outcomes (11)
Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly 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 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0 -6
Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Measured: Weeks 0 -6
Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind 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 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 twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement
Measured: Weeks 0 -12
Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind 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 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0 -12
Change From Baseline in Daily Average 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 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Measured: Weeks 0 -6
Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period
PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.
Measured: Weeks 0 -12
Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.
Measured: Weeks 0 -6
Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Measured: Weeks 0 -12
Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
Measured: Weeks 0 -12
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Measured: Weeks 0 -12
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
Measured: Weeks 0 -12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Respiratory Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451541
- Sponsor's protocol ID
- SEP060-306
- Status last verified
- Apr 2014
- First submitted
- 11 Oct 2011
- Last updated
- 6 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No