To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:12/3/2016
Start Date:December 2003
End Date:February 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 (200µg Once Daily) in the Treatment of Seasonal Allergic Rhinitis (SAR) 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 SAR. 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 SAR to relevant seasonal allergen for a minimum of two years immediately
preceding the study season. The SAR 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 Mountain Cedar pollen known to induce SAR 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.

5. Female is of child-bearing 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 (T4).

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 or 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 Screening 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. Plans to travel outside the study area (the known pollen area for the investigative
site) for two or more consecutive days OR 5 or more days total during the 5-week
study period ( Baseline and Treatment Periods).

10. 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.

11. 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.

12. 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.

13. Previous participation in an intranasal ciclesonide study.

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

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
4
sites
Kerrville, Texas 78028
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Kerrville, TX
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Austin, Texas 78731
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Austin, TX
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New Braunfels, Texas 78130
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New Braunfels, TX
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San Antonio, Texas 78229
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San Antonio, TX
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