A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451541
• Other study ID #: SEP060-306
• 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

Related Conditions & MeSH terms

• PAR
• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

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