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.
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
Arkansas Pediatric Clinic, Little Rock, Arkansas 72205, United States
San Jose Multispecialty Medical Group, Inc, Baldwin Park, California 91706, United States
WCCT Global, LLC, Costa Mesa, California 92626, United States
Premier Health Research Center, Downey, California 90241, United States
Allergy, Asthma, Brochitis and Immunology Assoc Medical Group, Fountain Valley, California 92708, United States
Pediatric Care Medical Group, Huntington Beach, California 92647, United States
Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States
Allergy and Asthma Associates of Southern California, Mission Viejo, California 92691, United States
CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology, Orange, California 92868, United States
Center for Clinical Trials, LLC, Paramount, California 90723, United States
Peninsula Research Associates, Rolling Hills Estates, California 90274, United States
Capital Allergy & Respiratory Disease Center, Sacramento, California 95819, United States
Allergy & Asthma Medical Group and Research Center, APC, San Diego, California 92123, United States
Allergy Associates Medical Group, San Diego, California 92120, United States
Bensch Research Associates, Stockton, California 95207, United States
Asthma & Allergy Associates, PC, Colorado Springs, Colorado 80907, United States
Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States
Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, United States
Northeast Georgia Research Center, Gainesville, Georgia 30501, United States
DataQuest Medical Research, LLC, Lawerenceville, Georgia 30046, United States
Atlanta Allergy & Astma Clinic, Marietta, Georgia 30188, United States
Aeroallergy Research Laboratories of Savannah, Inc, Savannah, Georgia 31406, United States
Clinical Research Atlanta, Stockbridge, Georgia 30281, United States
Alzein Pediatrics, Evergreen Park, Illinois 60805, United States
Sneeze, Weeze, & Itch Associates, Normal, Illinois 61761, United States
Gordon D. Raphael, MD, Berthesda, Maryland 20814, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Creighton University Medical Center, Omaha, Nebraska 68131, United States
Atlantic Research Center, LLC, Ocean, New Jersey 07712, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
Catalyst Medical Center, Fargo, North Dakota 58103, United States
Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States
Baker Allergy Asthma and Dermatology Research Center LLC, Lake Oswego, Oregon 97035, United States
Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States
Allergy Associates Research Center, Portland, Oregon 97202, United States
Asthma and Allergy Research Associates, Upland, Pennsylvania 19013, United States
Asthma, Nasal Disease & Allergy Research Center of New England, Providence, Rhode Island 02906, United States
National Allergy, Asthma, and Uticaria Centers of Charleston, PA, Charleston, South Carolina 29407, United States
Spartanburg Medical Research, Spartanburg, South Carolina 29303, United States
DCT - Anchor, LLC dba Discovery Clinical Trials, Arlington, Texas 76018, United States
Discovery Clinical Trials, Arlington, Texas 76018, United States
Benchmark Research, Austin, Texas 78705, United States
Isis Clinical Research, LLC, Austin, Texas 78731, United States
Sirius Clinical Research LLC, Austin, Texas 78759, United States
TTS Research Center, Boeme, Texas 78006, United States
Research Across America, Carroliton, Texas 75010, United States
Dallas Allergy Immunology Research, Dallas, Texas 75230, United States
Pharmaceutical Research and Consulting, Dallas, Texas 75231, United States
Western Sky Medical Research, El Paso, Texas 79903, United States
Benchmark Research, Fort Worth, Texas 76135, United States
Kerrville Research Associates, Kerrville, Texas 78028, United States
Live Oak Allergy and Asthma Clinic, Live Oak, Texas 78233, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
ACRC Trials, Plano, Texas 75024, United States
North Texas Family Medicine, Plano, Texas 75093, United States
Benchmark Research, San Angelo, Texas 76904, United States
Allergy and Asthma Research Center, PA, San Antonio, Texas 78229, United States
DCT - Barlite Dba Discovery Clinical Trials, San Antonio, Texas 78224, United States
DCT-Westover Hills, Dba Discovery Clinical Trials, San Antonio, Texas 78251, United States
San Antonio Ear, Nose & Throat Research, San Antonio, Texas 78229, United States
Sun Research Institute, San Antonio, Texas 78215, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Pediatric Healthcare of Northwest Houston, Tomball, Texas 77375, United States
Allergy & Asthma Care of Waco, Waco, Texas 76712, United States
Allergy Asthma Research Institute, Waco, Texas 76712, United States
Ericksen Research and Development, Clinton, Utah 84015, United States