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

Use our guide to learn which trials are right for you!

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
Madison, Wisconsin 53792
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
Brick, New Jersey 08724
2430
mi
from 91732
Brick, NJ
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Denver, Colorado 80206
820
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Encinitas, California 92024
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
Fort Worth, Texas 76132
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Houston, Texas 77084
1370
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Jupiter, Florida 33458
2296
mi
from 91732
Jupiter, FL
Click here to add this to my saved trials
Long Beach, California 90806
28
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
33
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
37
mi
from 91732
Mission Viejo, CA
Click here to add this to my saved trials
Missoula, Montana 59804
906
mi
from 91732
Missoula, MT
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
2586
mi
from 91732
North Dartmouth, MA
Click here to add this to my saved trials
Raleigh, North Carolina 27612
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
Rockville, Maryland 20850
2279
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
San Diego, California 92123
102
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Jose, California 95117
312
mi
from 91732
San Jose, CA
Click here to add this to my saved trials
Skillman, New Jersey 08558
2396
mi
from 91732
Skillman, NJ
Click here to add this to my saved trials
St. Louis, Missouri 63141
1549
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials
Sylvania, Ohio 43560
1929
mi
from 91732
Sylvania, OH
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2122
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials