A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Ciclesonide nasal aerosol 37 mcg; ciclesonide nasal aerosol 74 mcg; Placebo
Intervention description: 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 - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg; Placebo - one actuation per nostril
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 847.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Seasonal Allergic Rhinitis; Ciclesonide; Ciclesonide Nasal Aerosol

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.
    

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