Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Ciclesonide HFA Nasal Aerosol 320 mcg; Ciclesonide HFA Nasal Aerosol 160 mcg; HFA Nasal Aerosol placebo; Ciclesonide Aqueous Nasal Spray 200 mcg; AQ Nasal Spray Placebo; Placebo plus Dexamethasone HFA; Placebo AQ plus Dexamethasone 6 mg
Intervention description: Ciclesonide HFA Nasal Aerosol 320 μg once daily; Ciclesonide HFA Nasal Aerosol 160 μg once daily; HFA Nasal Aerosol placebo once daily; Ciclesonide Aqueous Nasal Spray 200 mcg once daily; AQ Nasal Spray Placebo once daily; Dexamethasone capsules 6 mg once daily; Placebo AQ plus Dexamethasone 6 mcg capsules once daily
Intervention MeSH terms: Ciclesonide; Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous
      (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Give written informed consent and assent, including privacy authorization as well as
             adherence to concomitant medication withholding periods, prior to participation.

          -  Subject must be in general good health (defined as the absence of any clinically
             relevant abnormalities as determined by the Investigator) based on screening physical
             examination, medical history, and clinical laboratory values (Hematology, Chemistries
             and Urinalysis).

          -  If any of the screening Hematology, Chemistries, or Urinalysis are not within the
             clinical laboratory's reference range, then the subject can be included only if the
             Investigator judges the deviations to be not clinically significant.

          -  A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds,
             animal dander) for a minimum of two years 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.

          -  A demonstrated sensitivity to at least one allergen known to induce PAR (house dust
             mite, animal dander, cockroach, and molds) based on a documented result with a
             standard skin-prick test either within 90 days 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 negative control wheal for the skin prick test. The subject's positive
             allergen test must be consistent with the medical history of PAR and must be present
             in the subject's environment throughout the study.

          -  Subject, if female, must have a negative serum pregnancy test at screening. Females of
             childbearing potential must be instructed to and agree to avoid pregnancy during the
             study and must use an acceptable method of birth control.

               1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive,
                  transdermal or injectable contraceptive for at least 1 month prior to entering
                  the study with continued use throughout the study and for thirty days following
                  study participation.

               2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide
                  while participating in the study.

               3. Abstinence.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  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 last 120 days prior to the Screening visit.

          -  Subject is, in the investigator's judgement, having a seasonal exacerbation at the
             time of screening.

          -  Participation in any investigational drug trial within the 30 days preceding the
             Screening visit or planned participation in another investigational drug trial at any
             time during this trial.

          -  A known hypersensitivity to any corticosteroid or any of the excipients in the
             formulation of ciclesonide.

          -  History of a respiratory infection or disorder [including, but not limited to
             bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)] within the
             14 days preceding the Screening visit.

          -  History of alcohol or drug abuse within 2 years preceding the Screening visit.

          -  History of a positive test for HIV, hepatitis B or hepatitis C.

          -  Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
             routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene
             antagonists, etc.); intermittent use (less than or equal to 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.

          -  Expected use of any disallowed concomitant medications during the treatment period.

          -  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.

          -  Previous randomization in an intranasal ciclesonide HFA nasal aerosol study.

          -  Non-vaccinated exposure to or active infection with, chickenpox or measles within the
             21 days preceding the Screening Visit.

          -  Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater
             during the study period or planned 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.

          -  Study participation by clinical investigator site employees and/or their immediate
             relatives who reside in the same household.

          -  Study participation by more than one subject from the same household.

          -  Have any of the following conditions that are judged by the investigator to be
             clinically significant and/or affect the subject's ability to participate in the
             clinical trial: impaired hepatic function including alcohol related liver disease or
             cirrhosis; history of ocular disturbances, eg, glaucoma or posterior subcapsular
             cataracts; any systemic infection hematological, hepatic, renal, endocrine (except for
             controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism;
             gastrointestinal disease; malignancy (excluding basal cell carcinoma); current
             neuropsychological condition with or without drug therapy

          -  Any condition that, in the judgment of the investigator, would preclude the subject
             from completing the protocol with capture of the assessments as written.