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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458275
• Other study ID #: SEP060-305
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: April 16, 2014
• Start date: November 2011
• Est. completion date: March 2013

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 2-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-old diagnosed with SAR.

Description:

This is a 2-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-old diagnosed with SAR.

This study will consist of the following:

Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this period, subjects will be randomized to double-blind treatment with either ciclesonide nasal aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total duration of subject participation will be approximately 2 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• 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.

• 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 SAR to any relevant dominant seasonal allergen for a minimum of one to two years immediately preceding the study Screening Visit. The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and is expected to require treatment throughout the entire study period.

• Has a demonstrated sensitivity to a relevant dominant seasonal allergen known to induce SAR based on a documented result with a standard skin prick test either within 12 months prior to screening or performed at the screening visit. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal (normal saline) for the skin prick test. The subject's positive allergen test must be consistent with the medical history of SAR, 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 Allergic Rhinitis diary and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (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 (SARS), 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.

• Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.

• Plans to leave the study area (the known pollen area for the investigative site) for longer than 24 hours during the Single-blind Placebo Run-in period.

• Is expecting to use any disallowed concomitant medications during the treatment period.

• 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.

• 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 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 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

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

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 mcg
• 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 actuation per nostril

Locations

Country	Name	City	State
United States	DCT - Anchor, LLC dba Discovery Clinical Trials	Arlington	Texas
United States	Discovery Clinical Trials	Arlington	Texas
United States	Benchmark Research	Austin	Texas
United States	Isis Clinical Research, LLC	Austin	Texas
United States	Sirius Clinical Research LLC	Austin	Texas
United States	San Jose Multispecialty Medical Group, Inc	Baldwin Park	California
United States	Gordon D. Raphael, MD	Berthesda	Maryland
United States	TTS Research Center	Boeme	Texas
United States	Research Across America	Carroliton	Texas
United States	National Allergy, Asthma, and Uticaria Centers of Charleston, PA	Charleston	South Carolina
United States	Ericksen Research and Development	Clinton	Utah
United States	Asthma & Allergy Associates, PC	Colorado Springs	Colorado
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	WCCT Global, LLC	Costa Mesa	California
United States	Dallas Allergy Immunology Research	Dallas	Texas
United States	Pharmaceutical Research and Consulting	Dallas	Texas
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Premier Health Research Center	Downey	California
United States	Western Sky Medical Research	El Paso	Texas
United States	Alzein Pediatrics	Evergreen Park	Illinois
United States	Catalyst Medical Center	Fargo	North Dakota
United States	Benchmark Research	Fort Worth	Texas
United States	Allergy, Asthma, Brochitis and Immunology Assoc Medical Group	Fountain Valley	California
United States	Northeast Georgia Research Center	Gainesville	Georgia
United States	Pediatric Care Medical Group	Huntington Beach	California
United States	Pediatric Care Medical Group, Inc.	Huntington Beach	California
United States	Kerrville Research Associates	Kerrville	Texas
United States	Baker Allergy Asthma and Dermatology Research Center LLC	Lake Oswego	Oregon
United States	DataQuest Medical Research, LLC	Lawerenceville	Georgia
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	Live Oak Allergy and Asthma Clinic	Live Oak	Texas
United States	Atlanta Allergy & Astma Clinic	Marietta	Georgia
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Allergy and Asthma Associates of Southern California	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Weeze, & Itch Associates	Normal	Illinois
United States	Atlantic Research Center, LLC	Ocean	New Jersey
United States	Creighton University Medical Center	Omaha	Nebraska
United States	CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology	Orange	California
United States	Center for Clinical Trials, LLC	Paramount	California
United States	ACRC Trials	Plano	Texas
United States	North Texas Family Medicine	Plano	Texas
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Allergy Associates Research Center	Portland	Oregon
United States	Asthma, Nasal Disease & Allergy Research Center of New England	Providence	Rhode Island
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Capital Allergy & Respiratory Disease Center	Sacramento	California
United States	Benchmark Research	San Angelo	Texas
United States	Allergy and Asthma Research Center, PA	San Antonio	Texas
United States	DCT - Barlite Dba Discovery Clinical Trials	San Antonio	Texas
United States	DCT-Westover Hills, Dba Discovery Clinical Trials	San Antonio	Texas
United States	San Antonio Ear, Nose & Throat Research	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center, APC	San Diego	California
United States	Allergy Associates Medical Group	San Diego	California
United States	Aeroallergy Research Laboratories of Savannah, Inc	Savannah	Georgia
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Bensch Research Associates	Stockton	California
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Pediatric Healthcare of Northwest Houston	Tomball	Texas
United States	Asthma and Allergy Research Associates	Upland	Pennsylvania
United States	Allergy & Asthma Care of Waco	Waco	Texas
United States	Allergy Asthma Research Institute	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Weeks 0 - 2	No
Secondary	Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Weeks 0 - 2	No
Secondary	Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.	TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Weeks 0 - 2	No
Secondary	Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the 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 and the individual domain scores are the means of the items in those domains.	Weeks 0 - 2	No
Secondary	Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. 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 two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.	Weeks 0 - 2	No
Secondary	Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.	TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent; = mild; = moderate; = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement	Weeks 0 - 2	No
Secondary	Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period	The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.	Weeks 0 - 2	No
Secondary	Number of Subjects Experiencing Treatment-emergent AEs	Treatment-Emergent Adverse Events Occurring in = 2% of Subjects in Any Treatment Group (ITT Population)	Weeks 0 - 3	No
Secondary	Percentage of Subjects Experiencing Treatment-emergent AEs	Treatment-Emergent Adverse Events Occurring in = 2% of Subjects in Any Treatment Group (ITT Population)	Weeks 0 - 3	No
Secondary	Treatment-emergent AEs Causing Study Medication Discontinuation		Weeks 0 - 3	No
Secondary	Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation		Weeks 0 - 3	No
Secondary	Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation		Weeks 0 - 3	No