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

Completed · Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis, Perennial Allergic Rhinitis

In brief

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).

Key facts

Study ID

NCT00953147

Run by

Sumitomo Pharma America, Inc.

People needed

1110

Starts

2009-08-01

Expected to finish

2010-05-01

Last updated by the study team

2012-06-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
• Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
• 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.
• Study participation by clinical investigator site employees and/or their immediate relatives who reside in the same household.
• Study participation by more than one subject from the same household.
• 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
• history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts
• any systemic infection
• hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism)
• gastrointestinal disease
• malignancy (excluding basal cell carcinoma)
• current neuropsychological condition with or without drug therapy • Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.

Where it is running

• 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
• Colorado Allergy and Asthma Centers — Denver, Colorado, United States
• Clinical Research Atlanta — Atlanta, Georgia, United States
• DataQuest Medical Research, LLC — Lawrenceville, Georgia, United States
• Allergy and Asthma Consultants, PC — Lilburn, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Clinical Research Center of Indiana — Indianapolis, Indiana, United States
• Gordon D. Raphael, MD — Bethesda, Maryland, United States
• Northeast Medical Research Associates, Inc. — North Dartmouth, Massachusetts, United States
• The Clinical Research Center, LLC — St Louis, Missouri, United States
• Clinical Research Group of Montana — Bozeman, Montana, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• Allergy and Asthma Center of NC — High Point, North Carolina, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Toledo Center for Clinical Research — Sylvania, Ohio, United States
• Allergy and Asthma Research Group — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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