Clinical trial NCT01458275: A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Ciclesonide
Ciclesonide Nasal Aerosol
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 847
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Weeks 0 - 2
Secondary outcomes:
measure: 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
timeFrame: Weeks 0 - 2
measure: 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.
timeFrame: Weeks 0 - 2
measure: Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.
timeFrame: Weeks 0 - 2
measure: Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period
timeFrame: Weeks 0 - 2
measure: 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.
timeFrame: Weeks 0 - 2
measure: Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period
timeFrame: Weeks 0 - 2
measure: Number of Subjects Experiencing Treatment-emergent AEs
timeFrame: Weeks 0 - 3
measure: Percentage of Subjects Experiencing Treatment-emergent AEs
timeFrame: Weeks 0 - 3
measure: Treatment-emergent AEs Causing Study Medication Discontinuation
timeFrame: Weeks 0 - 3
measure: Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Weeks 0 - 3
measure: Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Weeks 0 - 3
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Baldwin Park
country: United States
facility: San Jose Multispecialty Medical Group, Inc
state: California
city: Costa Mesa
country: United States
facility: WCCT Global, LLC
state: California
city: Downey
country: United States
facility: Premier Health Research Center
state: California
city: Fountain Valley
country: United States
facility: Allergy, Asthma, Brochitis and Immunology Assoc Medical Group
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc.
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Mission Viejo
country: United States
facility: Allergy and Asthma Associates of Southern California
state: California
city: Orange
country: United States
facility: CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Capital Allergy & Respiratory Disease Center
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center, APC
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Gainesville
country: United States
facility: Northeast Georgia Research Center
state: Georgia
city: Lawerenceville
country: United States
facility: DataQuest Medical Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Atlanta Allergy & Astma Clinic
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah, Inc
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Evergreen Park
country: United States
facility: Alzein Pediatrics
state: Illinois
city: Normal
country: United States
facility: Sneeze, Weeze, & Itch Associates
state: Illinois
city: Berthesda
country: United States
facility: Gordon D. Raphael, MD
state: Maryland
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Catalyst Medical Center
state: North Dakota
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Lake Oswego
country: United States
facility: Baker Allergy Asthma and Dermatology Research Center LLC
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: Charleston
country: United States
facility: National Allergy, Asthma, and Uticaria Centers of Charleston, PA
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Arlington
country: United States
facility: DCT - Anchor, LLC dba Discovery Clinical Trials
state: Texas
city: Arlington
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Isis Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research LLC
state: Texas
city: Boeme
country: United States
facility: TTS Research Center
state: Texas
city: Carroliton
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Dallas Allergy Immunology Research
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: Live Oak
country: United States
facility: Live Oak Allergy and Asthma Clinic
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: DCT - Barlite Dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Allergy and Asthma Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose & Throat Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: San Antonio
country: United States
facility: DCT-Westover Hills, Dba Discovery Clinical Trials
state: Texas
city: Tomball
country: United States
facility: Pediatric Healthcare of Northwest Houston
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Care of Waco
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: