The primary objective of this study is to demonstrate the safety of three dose levels of
ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once
daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to
measure serum concentrations of ciclesonide and its active metabolite under steady state
conditions at three time points corresponding to the presumed peak and trough exposure after
six weeks of administration.
In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of
treatment at various timepoints and a physician assessment of nasal symptoms at endpoint
1. Male or female between the ages of 2 and 5 years, inclusive
2. General good health, and free of any concomitant conditions or treatment that could
interfere with study conduct, influence the interpretation of study
observations/results, or put the patient at increased risk during the trial
3. A demonstrated sensitivity to at least one allergen known to induce PAR through a
standard prick skin test within one year of study start. A positive test is defined
as a wheal diameter at least 3mm larger than the control wheal for th eprick test
4. Parent or legal guardian is capable of understanding the requirements, risks, and
benefits of study participation, and, as judged by the investigator, capable of
giving informed consent and comply with all study requirements (visits,
5. A history of PAR for a minimum of 3 months preceding the study screening visit (B0).
The PAR must have been of sufficient severity to require treatment (either continuous
or intermittent) in the past and in the investigators judgment is expected to
continue to require treatment for the study duration.
1. History of physical findings of nasal pathology, including nasal polyps (within the
last 60 days) or other clinically significant respiratory tract malformations, recent
nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic
rhinitis or rhinitis medicamentosa (within the last 60 days).
2. Participation in any investigational drug trial within the 30 days preceding the
Screening Visit (B0) or at any time during the trial
3. A known hypersensitivity to any corticosteroid or any of the excipients in the
4. History of a respiratory infection or disorder [including, but not limited to
bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute
respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit, or
development of a respiratory infection during the Screening Visit (B0)
5. History of a positive test for HIV, hepatitis B or hepatitis C.
6. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
routine use of b-agonists and any controller drugs (e.g. theophylline, leukotrienes,
etc.) intermittent use of b-agonists is acceptable
7. Use of any prohibited concomitant medications within the prescribed (per protocol)
withdrawal periods prior to the screening visit (B0) and during the entire screening
period and treatment duration
8. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening
9. 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.
10. Non-vaccinated exposure to, or infection with, chickenpox or measles within the 21
days preceding the Screening Visit (B0).
11. Exposure to systemic corticosteroids for any indication, chronic or intermittent
(e.g.: contact dermatitis), during the past 2 months, or presence of an underlying
condition that can reasonably be expected to require treatment with corticosteroids
during the course of the study.
12. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for
dermatological conditions during the past 1 month, or presence of an underlying
condition that can reasonably be expected to require treatment with such preparations
during the course of the study.
13. Intraocular pressure at the screening visit (B0) of 21 mm Hg or greater or failed
reading at the screening Visit (B0)
14. Glaucoma requiring treatment
15. Use of antiepileptic drugs for epilepsy within 30 days of the screening visit (B0) or
anytime during the treatment period.
16. Initiation of pimecrolimus 1% cream or tacrolimus ointment 0.1% or 0.03% during the
study period or planned dose escalation during the study period. However, initiation
of these creams/ointments 30 days or more prior to the screening Visit (B0) AND use
of a stable (maintenance) dose during the study period may be considered for