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)

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654536
• Other study ID #: SEP060-401
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2012
• Last updated: July 23, 2014
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• ciclesonide nasal aerosol
ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)
• ciclesonide nasal spray
ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

Locations

Country	Name	City	State
United States	Isis Clinical Research, LLC	Austin	Texas
United States	Sirius Clinical Research LLC	Austin	Texas
United States	Gordon D Raphael, MD	Bethesda	Maryland
United States	Valley Clinical Research Center	Bethlehem	Pennsylvania
United States	Clinical Research Group of Montanta	Bozeman	Montana
United States	Ocean Allergy & Respiratory Research Center	Brick	New Jersey
United States	National Allergy, Asthma & Uticaria Centers of Charleston, P.A.	Charleston	South Carolina
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	Pharmaceutical Research and Consulting Inc.	Dallas	Texas
United States	Medical Education and Research Management Services of New England	Gardner	Massachusetts
United States	Allergy and Asthma Center of NC, PA	High Point	North Carolina
United States	Kerrville Research Associates, PA	Kerrville	Texas
United States	DataQuest Medical Research LLC	Lawerenceville	Georgia
United States	Asthma & Allergy Consultants, PC	Lilburn	Georgia
United States	Clinical Research Institute Inc.	Minneappolis	Minnesota
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts
United States	Atlantic Research Center, LLC	Ocean	New Jersey
United States	CHOC PSF AMC - Division of Allergy, Asthma and Immunology	Orange	California
United States	Allergy Assocaites Research Center	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Biogenics Research Institute	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy Associates Medical Group Inc.	San Diego	California
United States	ASTHMA Inc. Clinical Research Center	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	The Clinical Research Center, LLC	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California
United States	Asthma and Allergy Research Associates	Upland	Pennsylvania
United States	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)		0-6 months	Yes
Primary	The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)		0-6 months	Yes
Secondary	The Number of Subjects Experiencing Treatment Emergent Nasal AEs.		0-6 months	Yes
Secondary	The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.		0-6 months	Yes
Secondary	The Number of Subjects Experiencing Treatment Emergent AEs.		0-6 months	Yes
Secondary	The Percentage of Subjects Experiencing Treatment Emergent AEs.		0-6 months	Yes
Secondary	The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).		0-6 months	Yes
Secondary	The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).		0-6 months	Yes
Secondary	The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.		0-6 months	Yes
Secondary	The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.		0-6 months	Yes
Secondary	Number of Subjects With Development of or Worsening in Lens Opacities.		0-6 months	Yes
Secondary	Percentage of Subjects With Development of or Worsening in Lens Opacities.		0-6 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.		0-6 months	Yes
Secondary	Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.		0-6 months	Yes