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.
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.
Arkansas Pediatric Clinic, Little Rock, Arkansas 72205, United States; Recruiting
Study Coordinator, Phone: 501-664-4117
West Coast Clinical Trials, LLC, Costa Mesa, California 92626, United States; Recruiting
Study Coordinator, Phone: 714-668-1500
Premier Health Research Center, Downey, California 90241, United States; Recruiting
Study Coordinator, Phone: 562-904-2123
Allergy and Asthma Specialists Medical Group, Huntington Beach, California 92647, United States; Recruiting
Study Coordinator, Phone: 714-848-8585
Clinica Medica San Miguel, Los Angeles, California 90015, United States; Recruiting
Study Coordinator, Phone: 213-749-2585
Allergy and Asthma Assoc of Southern CA, Mission Veijo, California 92691, United States; Recruiting
Study Coordinator, Phone: 949-347-8700
Center for Clinical Trials, LLC, Paramount, California 90723, United States; Recruiting
Study Coordinator, Phone: 562-633-5101
Allergy Associates Medical Group, San Diego, California 92120, United States; Recruiting
Study Coordinator, Phone: 619-229-2355
Allergy and Asthma Medical Group & Research Center, San Diego, California 92123, United States; Recruiting
Study Coordinator, Phone: 858-268-2368
Sansum Clinic, Santa Barbara, California 93110, United States; Recruiting
Study Coordinator, Phone: 805-681-7836
Colorado Allergy and Asthma Centers, PC, Centennial, Colorado 80112, United States; Recruiting
Study Coordinator, Phone: 303-632-3646
IMMUNOe International Research Centers, Centennial, Colorado 80112, United States; Recruiting
Study Coordinator, Phone: 303-773-9000
Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States; Recruiting
Study Coordinator, Phone: 719-955-1939
Ashtma and Allergy Associates, Pueblo, Colorado 81001, United States; Recruiting
Study Coordinator, Phone: 719-564-2503
DataQuest Medical Research, LLC, Lawerenceville, Georgia 30045, United States; Recruiting
Study Coordinator, Phone: 770-513-3921
Atlanta Allergy and Asthma Clinic, Stockbridge, Georgia 30281, United States; Recruiting
Study Coordinator, Phone: 770-996-5354
Clinical Research Atlanta, Stockton, Georgia 30281, United States; Recruiting
Study Coordinator, Phone: 770-507-6867
Sneeze, Wheeze, & Itch Associates, LLC, Normal, Illinois 61761, United States; Recruiting
Study Coordinator, Phone: 309-452-0995
Iowa Clinical Research Organization, Iowa City, Iowa 52240, United States; Recruiting
Study Coordinator, Phone: 319-338-5552
Family Allergy and Asthma Research Institute, Louisville, Kentucky 40215, United States; Recruiting
Study Coordinator, Phone: 502-368-0732
Gordon Raphael, MD, Bethesda, Maryland 20814, United States; Recruiting
Study Coordinator, Phone: 301-907-3476
Northeast Medical Research Associates Inc, North Dartmouth, Massachusetts 02747, United States; Recruiting
Study Coordinator, Phone: 508-992-7595
Clinical Research Institute Inc, Plymouth, Minnesota 55441, United States; Recruiting
Study Coordinator, Phone: 763-744-1140
Clinical Research Group of Montana, Bozeman, Montana 59718, United States; Recruiting
Study Coordinator, Phone: 406-585-2444
The Asthma and Allergy Center, PC, Bellevue, Nebraska 68123, United States; Recruiting
Study Coordinator, Phone: 402-592-2055
Boys Town National Research Hospital, Boys Town, Nebraska 68010, United States; Recruiting
Study Coordinator, Phone: 402-778-6890
Atlantic Research Center LLC, Ocean, New Jersey 07712, United States; Recruiting
Study Coordinator, Phone: 732-695-2555, Ext: 111
Island Medical Research P.C., Rockville Center, New York 11570, United States; Recruiting
Study Coordinator, Phone: 516-536-4863
Sterling Research Group Ltd, Cincinnati, Ohio 45246, United States; Recruiting
Study Coordinator, Phone: 513-671-8080
Senders Pediatrics, Cleveland, Ohio 44121, United States; Recruiting
Study Coordinator, Phone: 216-291-9210
Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States; Recruiting
Study Coordinator, Phone: 419-885-5163
Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States; Recruiting
Study Coordinator, Phone: 405-286-9431
Cyn3rgy Research, Gresham, Oregon 97030, United States; Recruiting
Study Coordinator, Phone: 503-491-0714
Baker Allergy Asthma and Dermatolgy Research Center, LLC, Lake Oswego, Oregon 97035, United States; Recruiting
Study Coordinator, Phone: 503-534-2622
Allergy Associates Research Center, Portland, Oregon 97202, United States; Recruiting
Study Coordinator, Phone: 503-238-6233
Valley Clinical Research Center, Bethlehem, Pennsylvania 18020, United States; Recruiting
Study Coordinator, Phone: 601-954-9260
Valley Clinical Research Center, Bethlehem, Pennsylvania 18020, United States; Recruiting
Study Coordinator, Phone: 610-954-9260
Asthma and Allergy Research Associates, Upland, Pennsylvania 19013, United States; Recruiting
Study Coordinator, Phone: 610-876-2103
National Allergy, Ashtma, and Urticaria Centers of Charleston, PA, North Charleston, South Carolina 29406, United States; Recruiting
Study Coordinator, Phone: 843-820-1036
Sirius Clinical Research, Austin, Texas 787, United States; Recruiting
Study Coordinator, Phone: 512-345-8900
Isis Clinical Research LLC, Austin, Texas 78731, United States; Recruiting
Study Coordinator, Phone: 512-349-0999
TTS Research, Boerne, Texas 78006, United States; Recruiting
Study Coordinator, Phone: 830-249-3602
Pharmaceutical Research and Consulting, Inc., Dallas, Texas 75231, United States; Recruiting
Study Coordinator, Phone: 214-361-5555
Western Sky Medical Research, El Paso, Texas 79903, United States; Recruiting
Study Coordinator, Phone: 915-544-2557
Kerrville Research Associates, Kerrville, Texas 78028, United States; Recruiting
Study Coordinator, Phone: 830-896-1433
Central Texas Health Research, New Braunfels, Texas 78130, United States; Recruiting
Study Coordinator, Phone: 830-609-0900
Southwest Allergy and Asthma Research Center, PA, San Antonio, Texas 78229, United States; Recruiting
Study Coordinator, Phone: 210-616-0690
Sylvana Research Associates, San Antonio, Texas 78229, United States; Recruiting
Study Coordinator, Phone: 210-614-6673
Allergy and Asthma Research Institute, Waco, Texas 76712, United States; Recruiting
Study Coordinator, Phone: 254-751-1144, Ext: 232
J. Lewis Research Inc., Salt Lake City, Utah 84121, United States; Recruiting
Study Coordinator, Phone: 801-365-1032
J. Lewis Research Inc., Salt Lake City, Utah 84109, United States; Recruiting
Study Coordinator, Phone: 801-486-3021
J. Lewis Research Inc., South Jordan, Utah 84095, United States; Recruiting
Study Coordinator, Phone: 801-676-8109
PI-Coor Clinical Research, Burke, Virginia 22015, United States; Recruiting
Study Coordinator, Phone: 703-426-0800
Clinical Research Partners, LLC, Henrico, Virginia 23233, United States; Recruiting
Study Coordinator, Phone: 804-288-7425
ASTHMA, Inc., Seattle, Washington 98105, United States; Recruiting
Study Coordinator, Phone: 206-525-5520
