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

NCT ID: NCT01451541

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Perennial Allergic Rhinitis; PAR

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ciclesonide nasal aerosol 37mcg

ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily

Group Type: ACTIVE_COMPARATOR

Ciclesonide nasal aerosol 37 mcg

Intervention Type: DRUG

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 once daily

Group Type: ACTIVE_COMPARATOR

ciclesonide nasal aerosol 74 mcg

Intervention Type: DRUG

ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - one dose per nostril

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo

Placebo - one dose per nostril

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Respiratory Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

West Coast Clinical Trials, LLC

Costa Mesa, California, United States

Premier Health Research Center

Downey, California, United States

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, United States

Pediatric Care Medical Group

Huntington Beach, California, United States

Allergy and Asthma Assoc of Southern CA

Mission Veijo, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

Allergy Associates Medical Group

San Diego, California, United States

Allergy and Asthma Medical Group & Research Center

San Diego, California, United States

Sansum Clinic

Santa Barbara, California, United States

Colorado Allergy and Asthma Centers, PC

Centennial, Colorado, United States

IMMUNOe International Research Centers

Centennial, Colorado, United States

Storms Clinical Research Institute

Colorado Springs, Colorado, United States

Ashtma and Allergy Associates

Pueblo, Colorado, United States

DataQuest Medical Research, LLC

Lawerenceville, Georgia, United States

Aeroallergy Research Labs of Savannah

Savannah, Georgia, United States

Atlanta Allergy and Asthma Clinic

Stockbridge, Georgia, United States

Clinical Research Atlanta

Stockton, Georgia, United States

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, United States

College Park Family Care Center

Lenexa, Kansas, United States

Family Allergy and Asthma Research Institute

Louisville, Kentucky, United States

Gordon Raphael, MD

Bethesda, Maryland, United States

Northeast Medical Research Associates Inc

North Dartmouth, Massachusetts, United States

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, United States

Clinical Research Institute Inc

Plymouth, Minnesota, United States

Clinical Research of the Ozarks

Warrensburg, Missouri, United States

Clinical Research Group of Montana

Bozeman, Montana, United States

The Asthma and Allergy Center, PC

Bellevue, Nebraska, United States

Boys Town National Research Hospital

Boys Town, Nebraska, United States

Atlantic Research Center LLC

Ocean City, New Jersey, United States

Island Medical Research P.C.

Rockville Centre, New York, United States

Allergy and Asthma Center of NC, PA

High Point, North Carolina, United States

Catalyst Medical Center

Fargo, North Dakota, United States

Sterling Research Group Ltd

Cincinnati, Ohio, United States

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Amy Darter, MD

Oklahoma City, Oklahoma, United States

Cyn3rgy Research

Gresham, Oregon, United States

Baker Allergy Asthma and Dermatolgy Research Center, LLC

Lake Oswego, Oregon, United States

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, United States

Allergy Associates Research Center

Portland, Oregon, United States

Valley Clinical Research Center

Bethlehem, Pennsylvania, United States

Asthma and Allergy Research Associates

Upland, Pennsylvania, United States

National Allergy, Ashtma, and Urticaria Centers of Charleston, PA

North Charleston, South Carolina, United States

Isis Clinical Research LLC

Austin, Texas, United States

Sirius Clinical Research

Austin, Texas, United States

TTS Research

Boerne, Texas, United States

Pharmaceutical Research and Consulting, Inc.

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Kerrville Research Associates

Kerrville, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

Allergy and Asthma Research Institute

Waco, Texas, United States

J. Lewis Research Inc.

Salt Lake City, Utah, United States

J. Lewis Research Inc.

Salt Lake City, Utah, United States

J. Lewis Research Inc.

South Jordan, Utah, United States

PI-Coor Clinical Research

Burke, Virginia, United States

Clinical Research Partners, LLC

Henrico, Virginia, United States

ASTHMA, Inc.

Seattle, Washington, United States

Countries

United States

Other Identifiers

SEP060-306

Identifier Type: -

Identifier Source: org_study_id