A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Condition: Allergic Rhinitis; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Ciclesonide HFA 80 mcg; Ciclesonide HFA 160 mcg; Placebo
Intervention description: Ciclesonide HFA Nasal Aerosol 80 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.; Ciclesonide HFA Nasal Aerosol 160 mcg once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.; Placebo HFA Nasal Aerosol once daily for 6 months in the treatment of Perennial Allergic Rhinitis (PAR) in subjects 12 years and older.
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: 1110.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group,
      efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male
      and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).
    

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 based on screening physical examination,
             medical history, and clinical laboratory values.

          -  If any of the Screening visit 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 at the Screening visit to at least one allergen known to
             induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard
             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.

          -  Based upon subject's medical history, in the Investigator's judgment, the subject is
             unlikely to have a seasonal exacerbation during the first 6 weeks of double-blind
             treatment.

          -  Subject, if female ≤65 years of age, 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.

        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 60 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 participation 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.

          -  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.