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A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older | Clinical Trials | Clareo Health

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A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

A 6-Month Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of Once Daily Ciclesonide HFA Nasal Aerosol (80 and 160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

NCT00953147•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Detailed Description

This study will investigate the efficacy and safety of once daily ciclesonide HFA Nasal Aerosol for 26 weeks. The primary objective is to evaluate the efficacy of ciclesonide HFA (80 mcg and 160 mcg) over 6 weeks, compared to placebo in subjects with PAR. Secondary objectives are to evaluate safety and tolerability and quality of life after treatment with ciclesonide HFA (80 mcg and 160 mcg), over 6 weeks and over 6 months. The study will consist of a Screening period (7 to 21 (±3) days) from Visit 1 to Visit 2, followed by a Single-blind Placebo Run-in period (7 to 10 days) from Visit 2 to Visit 3, followed by a 6-month (26 weeks) double-blind treatment period (Visit 3 through Visit 11). Subjects who complete this study will be allowed to participate in a 6-month open-label extension study (Study 060-635). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
•Subject must be in general good health based on screening physical examination, medical history, and clinical laboratory values.
•If any of the Screening visit Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
•A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years 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 and require treatment throughout the entire study period.
•A demonstrated sensitivity at the Screening visit to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) using a standard skin-prick test. The subject's positive allergen test must be consistent with the medical history of PAR and must be present in the subject's environment throughout the study.
•Based upon subject's medical history, in the Investigator's judgment, the subject is unlikely to have a seasonal exacerbation during the first 6 weeks of double-blind treatment.
•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.

Exclusion Criteria

•Female subject who is pregnant or lactating.
•History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
•Subject is, in the investigator's judgement, having a seasonal exacerbation at the time of screening.
•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 and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable. Use of short acting beta-agonists for exercise-induced bronchospasm will be allowed.
•Expected use of any disallowed concomitant medications during the treatment period.
+14 more criteria

Locations (45)

Asthma and Allergy Specialists Medical Group

Huntington Beach, California, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Southern California Research

Mission Viejo, California, United States

CHOC PSF, AMC, Division of Allergy Asthma & Immunology

Orange, California, United States

California Allerga and Asthma Medical Group

Palmdale, California, United States

Allergy Associates Medical Group

San Diego, California, United States

Allergy and Asthma Medical Group and Research Center

San Diego, California, United States

Bensch Research Associates

Stockton, California, United States

Asthma and Allergy Associates, P.C.

Colorado Springs, Colorado, United States

Storms Clinical Research Institute

Colorado Springs, Colorado, United States

Key Dates

Start Date

August 1, 2009

Primary Completion Date

January 1, 2010

Completion Date

May 1, 2010

Last Updated

June 13, 2012

Enrollment

1,110

ACTUAL participants

Conditions

Allergic RhinitisPerennial Allergic Rhinitis

Interventions

Ciclesonide HFA 80 mcg

DRUG

Ciclesonide HFA 160 mcg

DRUG

Placebo

DRUG

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Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

Inclusion Criteria

Exclusion Criteria

A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

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