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)

NCT01654536 | Completed Phase 4 Results

• 1 other identifier: SEP060-401
• Study Type: interventional
• Target: 737
• Locations: 1 country
• Sites: 31

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.

Conditions

Perennial Allergic Rhinitis

Keywords

PAR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

Study Arms (2)

ciclesonide nasal aerosol

EXPERIMENTAL

ciclesonide nasal aerosol 74 mcg

Drug: ciclesonide nasal aerosol

ciclesonide nasal spray

ACTIVE COMPARATOR

ciclesonide nasal spray 200 mcg

Drug: ciclesonide nasal spray

Interventions

ciclesonide nasal aerosol DRUG

ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)

Also known as: Zetonna

ciclesonide nasal aerosol

ciclesonide nasal spray DRUG

ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

Also known as: Omnaris

ciclesonide nasal spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• impaired hepatic function including alcohol related liver disease or cirrhosis

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (31)

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

CHOC PSF AMC - Division of Allergy, Asthma and Immunology

Orange, California, 92868, United States

Location

Allergy Associates Medical Group Inc.

San Diego, California, 92120, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Storms Clinical Research Institute

Colorado Springs, Colorado, 80907, United States

Location

DataQuest Medical Research LLC

Lawerenceville, Georgia, 30046, United States

Location

Asthma & Allergy Consultants, PC

Lilburn, Georgia, 30047, United States

Location

Gordon D Raphael, MD

Bethesda, Maryland, 20814, United States

Location

Medical Education and Research Management Services of New England

Gardner, Massachusetts, 01440, United States

Location

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

Clinical Research Institute Inc.

Minneappolis, Minnesota, 55402, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Clinical Research Group of Montanta

Bozeman, Montana, 59718, United States

Location

Ocean Allergy & Respiratory Research Center

Brick, New Jersey, 08724, United States

Location

Atlantic Research Center, LLC

Ocean City, New Jersey, 07721, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Allergy and Asthma Center of NC, PA

High Point, North Carolina, 27262, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Allergy Assocaites Research Center

Portland, Oregon, 97202, United States

Location

Valley Clinical Research Center

Bethlehem, Pennsylvania, 18020, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

National Allergy, Asthma & Uticaria Centers of Charleston, P.A.

Charleston, South Carolina, 29406, United States

Location

Isis Clinical Research, LLC

Austin, Texas, 78731, United States

Location

Sirius Clinical Research LLC

Austin, Texas, 78759, United States

Location

Pharmaceutical Research and Consulting Inc.

Dallas, Texas, 75231, United States

Location

Kerrville Research Associates, PA

Kerrville, Texas, 78028, United States

Location

Central Texas Health Research

New Braunfels, Texas, 78130, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

ASTHMA Inc. Clinical Research Center

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion

1-866-503-6351

Study Officials

• Respiratory Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-07

Locations

US (31)