Clinical trial NCT01654536: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perennial Allergic Rhinitis
Keywords: PAR
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 737
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
timeFrame: 0-6 months
measure: The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
timeFrame: 0-6 months
Secondary outcomes:
measure: The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
timeFrame: 0-6 months
measure: The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
timeFrame: 0-6 months
measure: The Number of Subjects Experiencing Treatment Emergent AEs.
timeFrame: 0-6 months
measure: The Percentage of Subjects Experiencing Treatment Emergent AEs.
timeFrame: 0-6 months
measure: The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
timeFrame: 0-6 months
measure: The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
timeFrame: 0-6 months
measure: The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
timeFrame: 0-6 months
measure: The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
timeFrame: 0-6 months
measure: Number of Subjects With Development of or Worsening in Lens Opacities.
timeFrame: 0-6 months
measure: Percentage of Subjects With Development of or Worsening in Lens Opacities.
timeFrame: 0-6 months
measure: Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
timeFrame: 0-6 months
measure: Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
timeFrame: 0-6 months
measure: Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
timeFrame: 0-6 months
measure: Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Orange
country: United States
facility: CHOC PSF AMC - Division of Allergy, Asthma and Immunology
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group Inc.
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Lawerenceville
country: United States
facility: DataQuest Medical Research LLC
state: Georgia
city: Lilburn
country: United States
facility: Asthma & Allergy Consultants, PC
state: Georgia
city: Bethesda
country: United States
facility: Gordon D Raphael, MD
state: Maryland
city: Gardner
country: United States
facility: Medical Education and Research Management Services of New England
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Minneappolis
country: United States
facility: Clinical Research Institute Inc.
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montanta
state: Montana
city: Brick
country: United States
facility: Ocean Allergy & Respiratory Research Center
state: New Jersey
city: Ocean
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: High Point
country: United States
facility: Allergy and Asthma Center of NC, PA
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Portland
country: United States
facility: Allergy Assocaites Research Center
state: Oregon
city: Bethlehem
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma & Uticaria Centers of Charleston, P.A.
state: South Carolina
city: Austin
country: United States
facility: Isis Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting Inc.
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates, PA
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Seattle
country: United States
facility: ASTHMA Inc. Clinical Research Center
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: