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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01451541
Other study ID # SEP060-306
Secondary ID
Status Completed
Phase Phase 3
First received October 11, 2011
Last updated April 4, 2014
Start date October 2011
Est. completion date December 2012

Study information

Verified date April 2014
Source Sunovion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 848
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Ciclesonide nasal aerosol 37 mcg
ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37
ciclesonide nasal aerosol 74 mcg
ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Placebo
Placebo - one dose per nostril

Locations

Country Name City State
United States Isis Clinical Research LLC Austin Texas
United States Sirius Clinical Research Austin Texas
United States The Asthma and Allergy Center, PC Bellevue Nebraska
United States Gordon Raphael, MD Bethesda Maryland
United States Valley Clinical Research Center Bethlehem Pennsylvania
United States TTS Research Boerne Texas
United States Boys Town National Research Hospital Boys Town Nebraska
United States Clinical Research Group of Montana Bozeman Montana
United States PI-Coor Clinical Research Burke Virginia
United States Colorado Allergy and Asthma Centers, PC Centennial Colorado
United States IMMUNOe International Research Centers Centennial Colorado
United States Sterling Research Group Ltd Cincinnati Ohio
United States Storms Clinical Research Institute Colorado Springs Colorado
United States West Coast Clinical Trials, LLC Costa Mesa California
United States Pharmaceutical Research and Consulting, Inc. Dallas Texas
United States Premier Health Research Center Downey California
United States Western Sky Medical Research El Paso Texas
United States Catalyst Medical Center Fargo North Dakota
United States Cyn3rgy Research Gresham Oregon
United States Clinical Research Partners, LLC Henrico Virginia
United States Allergy and Asthma Center of NC, PA High Point North Carolina
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Allergy and Asthma Specialists Medical Group Huntington Beach California
United States Pediatric Care Medical Group Huntington Beach California
United States Kerrville Research Associates Kerrville Texas
United States Baker Allergy Asthma and Dermatolgy Research Center, LLC Lake Oswego Oregon
United States DataQuest Medical Research, LLC Lawerenceville Georgia
United States College Park Family Care Center Lenexa Kansas
United States Arkansas Pediatric Clinic Little Rock Arkansas
United States Family Allergy and Asthma Research Institute Louisville Kentucky
United States Clinical Research Institute of Southern Oregon, PC Medford Oregon
United States Allergy and Asthma Assoc of Southern CA Mission Veijo California
United States Central Texas Health Research New Braunfels Texas
United States Sneeze, Wheeze, & Itch Associates, LLC Normal Illinois
United States National Allergy, Ashtma, and Urticaria Centers of Charleston, PA North Charleston South Carolina
United States Northeast Medical Research Associates Inc North Dartmouth Massachusetts
United States Atlantic Research Center LLC Ocean New Jersey
United States Amy Darter, MD Oklahoma Oklahoma
United States Allergy, Asthma & Clinical Research Center Oklahoma City Oklahoma
United States Center for Clinical Trials, LLC Paramount California
United States Clinical Research Institute Inc Plymouth Minnesota
United States Allergy Associates Research Center Portland Oregon
United States Ashtma and Allergy Associates Pueblo Colorado
United States Island Medical Research P.C. Rockville Center New York
United States J. Lewis Research Inc. Salt Lake City Utah
United States J. Lewis Research Inc. Salt Lake City Utah
United States Sylvana Research Associates San Antonio Texas
United States Allergy and Asthma Medical Group & Research Center San Diego California
United States Allergy Associates Medical Group San Diego California
United States Sansum Clinic Santa Barbara California
United States Aeroallergy Research Labs of Savannah Savannah Georgia
United States ASTHMA, Inc. Seattle Washington
United States J. Lewis Research Inc. South Jordan Utah
United States Atlanta Allergy and Asthma Clinic Stockbridge Georgia
United States Clinical Research Atlanta Stockton Georgia
United States Toledo Center for Clinical Research Sylvania Ohio
United States Asthma and Allergy Research Associates Upland Pennsylvania
United States Allergy and Asthma Research Institute Waco Texas
United States Clinical Research of the Ozarks Warrensburg Missouri
United States Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Weeks 0-6 No
Secondary 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. Weeks 0 -6 No
Secondary 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. Weeks 0 -6 No
Secondary 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 Weeks 0 -12 No
Secondary 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. Weeks 0 -12 No
Secondary 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. Weeks 0 -6 No
Secondary 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. Weeks 0 -12 No
Secondary 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. Weeks 0 -6 No
Secondary Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs Weeks 0 -12 No
Secondary Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs Weeks 0 -12 No
Secondary Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Weeks 0 -12 No
Secondary Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation Weeks 0 -12 No
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