To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)
NCT ID: NCT00659750
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
418 participants
INTERVENTIONAL
2003-12-31
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Ciclesonide 200µg
Ciclesonide
200µg Ciclesonide versus Placebo
2
Placebo
Placebo
placebo
Interventions
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Ciclesonide
200µg Ciclesonide versus Placebo
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Altana/Nycomed
Encinitas, California, United States
Altana/Nycomed
Long Beach, California, United States
Altana/Nycomed
Los Angeles, California, United States
Altana/Nycomed
Mission Viejo, California, United States
Altana/Nycomed
San Diego, California, United States
Altana/Nycomed
San Jose, California, United States
Altana/Nycomed
Colorado Springs, Colorado, United States
Altana/Nycomed
Denver, Colorado, United States
Altana/Nycomed
Denver, Colorado, United States
Altana/Nycomed
Jupiter, Florida, United States
Altana/Nycomed
Rockville, Maryland, United States
Altana/Nycomed
North Dartmouth, Massachusetts, United States
Altana/Nycomed
Minneapolis, Minnesota, United States
Altana/Nycomed
St Louis, Missouri, United States
Altana/Nycomed
Missoula, Montana, United States
Altana/Nycomed
Brick, New Jersey, United States
Altana/Nycomed
Skillman, New Jersey, United States
Altana/Nycomed
Raleigh, North Carolina, United States
Altana/Nycomed
Winston-Salem, North Carolina, United States
Altana/Nycomed
Sylvania, Ohio, United States
Altana/Nycomed
Fort Worth, Texas, United States
Altana/Nycomed
Houston, Texas, United States
Altana/Nycomed
Madison, Wisconsin, United States
Countries
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Related Links
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BY9010-M1-402-RDS-2005-04-05.pdf
Other Identifiers
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BY9010/M1-402
Identifier Type: -
Identifier Source: org_study_id