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)

A 6 Month Randomized, Open Label, Parallel Group, Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: ciclesonide nasal aerosol; Drug: ciclesonide nasal spray

Detailed Description

This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.

• Study Type: Interventional
• Enrollment (Actual): 737
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California
    • Orange, California, United States, 92868
      • CHOC PSF AMC - Division of Allergy, Asthma and Immunology
    • San Diego, California, United States, 92120
      • Allergy Associates Medical Group Inc.
    • Stockton, California, United States, 95207
      • Bensch Research Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Storms Clinical Research Institute
  • Georgia
    • Lawerenceville, Georgia, United States, 30046
      • DataQuest Medical Research LLC
    • Lilburn, Georgia, United States, 30047
      • Asthma & Allergy Consultants, PC
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Gordon D Raphael, MD
  • Massachusetts
    • Gardner, Massachusetts, United States, 01440
      • Medical Education and Research Management Services of New England
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates, Inc.
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
  • Minnesota
    • Minneappolis, Minnesota, United States, 55402
      • Clinical Research Institute Inc.
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center, LLC
  • Montana
    • Bozeman, Montana, United States, 59718
      • Clinical Research Group of Montanta
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Ocean Allergy & Respiratory Research Center
    • Ocean, New Jersey, United States, 07721
      • Atlantic Research Center, LLC
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Allergy and Asthma Center of NC, PA
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97202
      • Allergy Assocaites Research Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18020
      • Valley Clinical Research Center
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • National Allergy, Asthma & Uticaria Centers of Charleston, P.A.
  • Texas
    • Austin, Texas, United States, 78731
      • ISIS Clinical Research, LLC
    • Austin, Texas, United States, 78759
      • Sirius Clinical Research LLC
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research and Consulting Inc.
    • Kerrville, Texas, United States, 78028
      • Kerrville Research Associates, PA
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Biogenics Research Institute
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
  • Washington
    • Seattle, Washington, United States, 98115
      • ASTHMA Inc. Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ciclesonide nasal aerosol; ciclesonide nasal aerosol 74 mcg	Drug: ciclesonide nasal aerosol; ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol); Other Names: Zetonna
Active Comparator: ciclesonide nasal spray; ciclesonide nasal spray 200 mcg	Drug: ciclesonide nasal spray; ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray); Other Names: Omnaris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)	0-6 months
The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)	0-6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.	0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.	0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs.	0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs.	0-6 months
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).	0-6 months
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).	0-6 months
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.	0-6 months
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.	0-6 months
Number of Subjects With Development of or Worsening in Lens Opacities.	0-6 months
Percentage of Subjects With Development of or Worsening in Lens Opacities.	0-6 months
Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye	0-6 months
Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye	0-6 months
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.	0-6 months
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.	0-6 months

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: PAR
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: SEP060-401