Clinical trial NCT01451541: A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
PAR
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 848
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 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.

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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: Weeks 0-6
Secondary outcomes:
measure: 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
timeFrame: Weeks 0 -6
measure: 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
timeFrame: Weeks 0 -6
measure: Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
timeFrame: Weeks 0 -12
measure: Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period
timeFrame: Weeks 0 -12
measure: Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment
timeFrame: Weeks 0 -6
measure: Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period
timeFrame: Weeks 0 -12
measure: Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]
timeFrame: Weeks 0 -6
measure: Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
timeFrame: Weeks 0 -12
measure: Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs
timeFrame: Weeks 0 -12
measure: Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Weeks 0 -12
measure: Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
timeFrame: Weeks 0 -12
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials, LLC
state: California
city: Downey
country: United States
facility: Premier Health Research Center
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Mission Veijo
country: United States
facility: Allergy and Asthma Assoc of Southern CA
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group & Research Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Centennial
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Pueblo
country: United States
facility: Ashtma and Allergy Associates
state: Colorado
city: Lawerenceville
country: United States
facility: DataQuest Medical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Labs of Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Atlanta Allergy and Asthma Clinic
state: Georgia
city: Stockton
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC
state: Illinois
city: Lenexa
country: United States
facility: College Park Family Care Center
state: Kansas
city: Louisville
country: United States
facility: Family Allergy and Asthma Research Institute
state: Kentucky
city: Bethesda
country: United States
facility: Gordon Raphael, MD
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates Inc
state: Massachusetts
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute Inc
state: Minnesota
city: Warrensburg
country: United States
facility: Clinical Research of the Ozarks
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: Bellevue
country: United States
facility: The Asthma and Allergy Center, PC
state: Nebraska
city: Boys Town
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center LLC
state: New Jersey
city: Rockville Center
country: United States
facility: Island Medical Research P.C.
state: New York
city: High Point
country: United States
facility: Allergy and Asthma Center of NC, PA
state: North Carolina
city: Fargo
country: United States
facility: Catalyst Medical Center
state: North Dakota
city: Cincinnati
country: United States
facility: Sterling Research Group Ltd
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Oklahoma
country: United States
facility: Amy Darter, MD
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Lake Oswego
country: United States
facility: Baker Allergy Asthma and Dermatolgy 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: Bethlehem
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: North Charleston
country: United States
facility: National Allergy, Ashtma, and Urticaria Centers of Charleston, PA
state: South Carolina
city: Austin
country: United States
facility: Isis Clinical Research LLC
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting, Inc.
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research
state: Virginia
city: Henrico
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: