To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:12/3/2016
Start Date:December 2003
End Date:April 2005

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray (200 mg Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older

The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as
a nasal spray once daily in patients with PAR. The secondary objectives are to evaluate
Quality-of-Life and safety.


Inclusion Criteria:

1. Male or female 12 years and older.

2. General good health, and free of any concomitant conditions or treatment that could
interfere with study conduct, influence the interpretation of study
observations/results, or put the patient at increased risk during the trial.

3. A history of PAR to relevant perennial allergen for a minimum of two years
immediately preceding the study.The PAR must have been of sufficient severity to have
required treatment(continuous or intermittent) in the past and in the investigator's
judgment, - is expected to require treatment throughout the entire study period.

4. A demonstrated sensitivity to at least one allergen known to induce PAR through a
standard prick test. A positive test is defined as a wheal diameter at least 3 mm
larger than the control wheal for the prick test. Documentation of a positive result
12 months prior to screening is acceptable. Additionally, the patient is expected to
be exposed to the PAR allergen that he/she has tested positive for via the skin prick
test for the duration of the study.

5. Female is of childbearing potential and is currently taking and will continue to use
a medically reliable method of contraception for the entire study duration (e.g.
oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine
devices or double-barrier protection). Women of childbearing potential, or less than
1 year postmenopausal, will require a negative serum pregnancy test at the Screening
Visit (B0) as well as at last on-treatment visit (T6).

6. Capable of understanding the requirements, risks, and benefits of study
participation, and, as judged by the investigator, capable of giving informed consent
and compliance with all study requirements (visits, record keeping, etc).

Exclusion Criteria:

1. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for
in vitro fertilization during the study period or for 30 days following the study
period.

2. History of physical findings of nasal pathology, including nasal polyps (within the
last 60 days) or other clinically significant respiratory tract malformations, recent
nasal biopsy (within the last 60 days), nasal trauma, or surgery and atrophic
rhinitis or rhinitis medicamentosa (within the last 60 days).

3. Participation in any investigational drug trial within the 30 days preceding the
Screening Visit.

4. A known hypersensitivity to any corticosteroid or any of the excipients in the
formulation.

5. History of a respiratory infection or disorder [including, but not limited to
bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu, severe acute
respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit, or
development of a respiratory infection during the Baseline Period.

6. History of alcohol or drug abuse within the preceding two years.

7. History of a positive test for HIV, hepatitis B or hepatitis C.

8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
routine use of b-agonists; intermittent use of b-agonists is acceptable.

9. Use of any prohibited concomitant medications within the prescribed (per protocol)
time since last dose period prior to the Screening Visit (B0) and during entire
treatment duration.

10. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening
Visit (B0). Low doses of antibiotics taken for prophylaxis are permitted if the
therapy was started prior to the Screening Visit AND is expected to continue
throughout the trial.

11. 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.

12. Previous participation in an intranasal ciclesonide study.

13. Non-vaccinated exposure to or active infection with, chickenpox or measles within the
21 days preceding the Screening Visit (B0).

14. Patients allergic to a seasonal aeroallergen, e.g. trees, grasses or weeds, with
seasonal exacerbation anticipated to occur-or occurring-during the study.

15. Exposure to systemic corticosteroids for any indication, chronic or intermittent
(e.g.: contact dermatitis), during the past 2 months, or presence of an underlying
condition that can reasonably be expected to require treatment with corticosteroids
during the course of the study.

16. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for
dermatological conditions during the past 1 month, or presence of an underlying
condition that can reasonably be expected to require treatment with such preparations
during the course of the study.
We found this trial at
22
sites
Colorado Springs, Colorado 80907
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Brick, New Jersey 08724
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Brick, NJ
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Denver, Colorado 80206
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Denver, CO
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Encinitas, California 92024
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Encinitas, CA
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Fort Worth, Texas 76132
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Fort Worth, TX
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Houston, Texas 77084
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Houston, TX
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Jupiter, Florida 33458
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Jupiter, FL
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Long Beach, California 90806
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Long Beach, CA
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Los Angeles, California 90025
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Los Angeles, CA
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Madison, Wisconsin 53792
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Madison, WI
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Mission Viejo, California 92691
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Mission Viejo, CA
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Missoula, Montana 59804
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Missoula, MT
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Raleigh, North Carolina 27612
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Raleigh, NC
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Rockville, Maryland 20850
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Rockville, MD
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San Diego, California 92123
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San Diego, CA
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San Jose, California 95117
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San Jose, CA
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Skillman, New Jersey 08558
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Skillman, NJ
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St. Louis, Missouri 63141
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St. Louis, MO
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Sylvania, Ohio 43560
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Sylvania, OH
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Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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