A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: ciclesonide nasal aerosol; ciclesonide nasal spray
Intervention description: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol); ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)
Intervention MeSH terms: Ciclesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 737.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: PAR

Summary:

      This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the
      nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered
      once daily to male and female subjects 12 years and older diagnosed with PAR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or Subject's parent/guardian gives written informed consent and assent,
             including privacy authorization as well as adherence to concomitant medication
             withholding periods, prior to participation.

          -  Male or female 12 years and older, as of the Screening visit.

          -  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.

          -  A history of PAR to a relevant perennial allergen (eg, house dust mites, cockroach,
             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 12 months, and require
             treatment throughout the entire study period.

          -  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:

               -  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.

               -  Barrier method of contraception, eg, condom and/or diaphragm with spermicide
                  while participating in the study.

               -  Abstinence.

          -  Subject must possess an educational level and degree of understanding of English that
             enables them to communicate suitably with the PI and study coordinator.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  Current physical findings of nasal polyps, septal perforation, or nasal ulceration.
             (Subjects showing significant progression of nasal pathology between screening and
             randomization would be excluded at the discretion of the investigator.]

          -  Planned insertion of nasal septal jewelry during the study period.

          -  Surgery (including biopsy) and atrophic rhinitis or rhinitis medicamentosa are not
             permitted within the last 30 days prior to the Screening visit.

          -  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.

          -  Use of chronic treatment with agents known to promote the development of cataracts
             (potassium-sparing diuretics and allopurinol).

          -  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.

          -  Use of nasal corticosteroids within 14 days, or ocular, oral or parenteral within 6
             months prior to randomization.

          -  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:

               1. impaired hepatic function including alcohol related liver disease or cirrhosis

               2. diabetes mellitus

               3. malignancy (excluding basal cell carcinoma)

          -  Any condition that, in the judgment of the investigator, would preclude the subject
             from completing the protocol with capture of the assessments as written Ocular
             Exclusion Criteria

          -  History of bacterial or viral infection of the eyes within 14 days of the Screening
             visit or current or history of ocular herpes simplex.

          -  Any use within 6 months prior to the randomization or planned use during the trial of
             a topical ocular corticosteroid, or intraocular or periocular injection of
             corticosteroids.

          -  Progressive retinal (including, but not limited to acute macular degeneration or
             unstable diabetic retinopathy) or optic nerve disease in either eye.

          -  Ocular injury/surgery in the last 6 months (including LASIK eye surgery, as well as
             any glaucoma intraocular surgery, including laser trabeculoplasty [ALT or SLT]).

          -  Any evidence of glaucomatous optic disc changes or a vertical cup:disc ratio > 0.8.

          -  Current or history of any glaucoma related diagnosis, including ocular hypertension,
             open-angle or closed-angle, as well as secondary or congenital glaucoma.

          -  Occludable angles by slit lamp examination (eg, peripheral anterior chamber less than
             or equal to one quarter of the peripheral corneal thickness), which may be confirmed
             by gonioscopy at the investigator's discretion..

          -  Current PSC cataract or previous history of cataract surgery.

          -  Current or history of congenital cataract or active or prior uveitis.

          -  Historical or current intraocular pressure of 22 mm Hg or higher in either eye.

          -  Inability to complete ocular examination, including: Inability to measure intraocular
             pressure, Pupillary diameter < 6 mm upon dilation , Significant media opacity in
             either eye that would exclude adequate posterior segment examination, Clinically
             significant corneal dystrophy, epithelial, or endothelial disease that would preclude
             visualization or intraocular pressure measurement, Corneal irregularities or scarring
             that in the investigator's judgment would impeded an accurate measurement of
             intraocular pressure or visualization of intraocular anatomy, Unwillingness to remove
             contact lenses for ocular examination, Subjects with LOCS III grade NO > 4.0, NC > 4.0
             and C > 4.0 in either eye

          -  Best-corrected visual acuity in either eye of 20/200 or worse at the screening ocular
             examination.

          -  Planned or anticipated ocular surgery during the next 6 months.

          -  Any condition that, in the judgment of the ophthalmologist, would preclude the subject
             from completing the protocol with capture of the assessments as written.