Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis; PAR
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: ciclesonide nasal aerosol; Placebo
Intervention description: ciclesonide nasal aerosol (74 mcg); Placebo
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: 89.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Perennial Allergic Rhinitis; PAR

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety
      study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered
      once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of
      PAR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gives written informed consent (parent/legal guardian) and assent (when appropriate,
             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 and ≥ 20 kg 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, animal dander) for a minimum of one 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 one 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 one year prior to the 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 of
             PAR, and the allergen must be present in the subject's environment throughout the
             study.

        Exclusion Criteria:

          -  Has a history of physical findings of nasal pathology, including nasal polyps or other
             clinically significant respiratory tract malformations; recent 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 a history of adrenal insufficiency.

          -  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.

          -  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.

          -  Has experienced significant blood loss within 60 days or loss of plasma within 72
             hours prior to the screening visit or intends to undergo elective surgery within 30
             days following end of study.

          -  Is a child or immediate 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 at
             the same time.

          -  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.