Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:11/24/2016
Start Date:November 2006
End Date:August 2007

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Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy

- The primary objective of this study is to evaluate the efficacy of the concomitant
administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide
nasal spray alone in patients (18 years or older) with perennial allergic rhinitis
(PAR) not adequately controlled on an intranasal corticosteroid or antihistamine
monotherapy

- The secondary objective is to investigate the safety of the concomitant administration
of ciclesonide nasal spray and azelastine nasal spray


Inclusion Criteria:

1. Male or female, 18 years of age or older at the B0 Visit.

2. General good health, and free of any concomitant conditions or treatment that in the
investigator's judgment 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 for a minimum of two years immediately preceding the Screening Visit
(B0). The PAR must have been of sufficient severity to require treatment(continuous
or intermittent) in the past with intranasal corticosteroids and/or antihistamines
and, in the investigator's judgment, experienced less than complete symptom
alleviation on this prior therapy. In addition, the patient is again expected to
require treatment throughout the study period.

4. A demonstrated sensitivity to at least one allergen known to induce PAR through a
standard prick test within one year of study start. A positive test is defined as a
wheal diameter at least 3 mm larger than the control (saline) wheal for the prick
test. Documentation of a positive result within 12 months prior to the Screening
Visit (B0) is acceptable.

5. Females of childbearing potential currently using contraception must 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).Females who are not sexually active must agree to use
double-barrier protection should they become active during the course of the study.
Women of childbearing potential, or less than 1 year postmenopausal, will require a
negative plasma pregnancy test at the Screening Visit (B0). Females will be
considered to be of non-child-bearing potential and will not require a urine
pregnancy test if at least one of the following apply:

- More than one year post-menopausal

- Had a hysterectomy

- Had bilateral ovariectomy or salpingectomy or tubal ligation

- Has congenital sterility

6. Patients on intranasal corticosteroids and antihistamines should be on a stable dose
for at least 4 weeks.

7. Patients must complete a 24-hour reflective total nasal symptom assessment at the
Screening Visit (B0) and score a total of 6 or greater (out of 12).

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

13. 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.

14. 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.

15. History of epilepsy or seizures (excluding febrile seizures).

16. History of coronary artery disease, uncontrolled hypertension, or other clinically
significant cardiovascular disease.

17. Patients using combination treatment for allergic rhinitis (e.g. intranasal
corticosteroid and antihistamine).

18. 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, might interfere with the study, require treatment or make
implementation of the protocol or interpretation of the study results difficult:

- Impaired hepatic function including alcohol-related liver disease or cirrhosis;

- History of ocular disturbances e.g. 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).

19. Clinical site employees and their immediate relatives are excluded from study
participation.
We found this trial at
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North Dartmouth, Massachusetts 02747
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Ashland, Oregon 97520
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Charleston, South Carolina 29414
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Colorado Springs, Colorado 80907
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Encinitas, California 92024
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Gainesville, Georgia 30501
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Lakewood, Colorado 80401
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Los Angeles, California 90025
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Milwaukee, Wisconsin 53209
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Mission Viejo, California 92691
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Newport News, Virginia 23606
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Novi, Michigan 48375
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Overland Park, Kansas 66210
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Papillion, Nebraska 68046
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Pittsburgh, Pennsylvania 15241
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Portland, Oregon 97213
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Raleigh, North Carolina 27612
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Richmond, Virginia 23226
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Rolla, Missouri 65401
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Skillman, New Jersey 08558
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South Burlington, Vermont 05403
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Stockbridge, Georgia 30281
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Upland, Pennsylvania 19013
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