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

NCT ID: NCT01458275

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 847 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Seasonal Allergic Rhinitis

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 37 mcg

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 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

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 actuation 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 mcg

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 actuation 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.
• 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

• 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

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

San Jose Multispecialty Medical Group, Inc

Baldwin Park, California, United States

WCCT Global, LLC

Costa Mesa, California, United States

Premier Health Research Center

Downey, California, United States

Allergy, Asthma, Brochitis and Immunology Assoc Medical Group

Fountain Valley, California, United States

Pediatric Care Medical Group, Inc.

Huntington Beach, California, United States

Pediatric Care Medical Group

Huntington Beach, California, United States

Allergy and Asthma Associates of Southern California

Mission Viejo, California, United States

CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology

Orange, California, United States

Center for Clinical Trials, LLC

Paramount, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Capital Allergy & Respiratory Disease Center

Sacramento, California, United States

Allergy Associates Medical Group

San Diego, California, United States

Allergy & Asthma Medical Group and Research Center, APC

San Diego, California, United States

Bensch Research Associates

Stockton, California, United States

Asthma & Allergy Associates, PC

Colorado Springs, Colorado, United States

Storms Clinical Research Institute

Colorado Springs, Colorado, United States

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, United States

Northeast Georgia Research Center

Gainesville, Georgia, United States

DataQuest Medical Research, LLC

Lawerenceville, Georgia, United States

Atlanta Allergy & Astma Clinic

Marietta, Georgia, United States

Aeroallergy Research Laboratories of Savannah, Inc

Savannah, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Alzein Pediatrics

Evergreen Park, Illinois, United States

Sneeze, Weeze, & Itch Associates

Normal, Illinois, United States

Gordon D. Raphael, MD

Berthesda, Maryland, United States

Clinical Research Institute

Plymouth, Minnesota, United States

Creighton University Medical Center

Omaha, Nebraska, United States

Atlantic Research Center, LLC

Ocean City, New Jersey, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Catalyst Medical Center

Fargo, North Dakota, United States

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Baker Allergy Asthma and Dermatology 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

Asthma and Allergy Research Associates

Upland, Pennsylvania, United States

Asthma, Nasal Disease & Allergy Research Center of New England

Providence, Rhode Island, United States

National Allergy, Asthma, and Uticaria Centers of Charleston, PA

Charleston, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, 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

TTS Research Center

Boeme, Texas, United States

Research Across America

Carroliton, Texas, United States

Dallas Allergy Immunology Research

Dallas, Texas, United States

Pharmaceutical Research and Consulting

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Kerrville Research Associates

Kerrville, Texas, United States

Live Oak Allergy and Asthma Clinic

Live Oak, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

ACRC Trials

Plano, Texas, United States

North Texas Family Medicine

Plano, Texas, United States

Benchmark Research

San Angelo, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

DCT - Barlite Dba Discovery Clinical Trials

San Antonio, Texas, United States

Allergy and Asthma Research Center, PA

San Antonio, Texas, United States

San Antonio Ear, Nose & Throat Research

San Antonio, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

DCT-Westover Hills, Dba Discovery Clinical Trials

San Antonio, Texas, United States

Pediatric Healthcare of Northwest Houston

Tomball, Texas, United States

Allergy & Asthma Care of Waco

Waco, Texas, United States

Allergy Asthma Research Institute

Waco, Texas, United States

Ericksen Research and Development

Clinton, Utah, United States

Countries

United States

Other Identifiers

SEP060-305

Identifier Type: -

Identifier Source: org_study_id