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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659750
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Ciclesonide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arm Intervention/treatment
Active Comparator: 1
Ciclesonide 200µg
Drug: Ciclesonide
200µg Ciclesonide versus Placebo

Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Average of AM and PM patient-reported instantaneous TNSS over 6 weeks of treatment. [ Time Frame: 6 weeks ]
  2. Physician Assessment of Overall Nasal Signs and Symptoms Severity (PANS) at Endpoint. [ Time Frame: 6 weeks ]
  3. RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at Endpoint [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659750

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United States, California
Encinitas, California, United States, 92924
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90025
Mission Viejo, California, United States, 92691
San Diego, California, United States, 92123
San Jose, California, United States, 95117
United States, Colorado
Colorado Springs, Colorado, United States, 80907
Denver, Colorado, United States, 80206
Denver, Colorado, United States, 80230
United States, Florida
Jupiter, Florida, United States, 33458
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Massachusetts
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Minneapolis, Minnesota, United States, 55402
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, Montana
Missoula, Montana, United States, 59804
United States, New Jersey
Brick, New Jersey, United States, 08724
Skillman, New Jersey, United States, 08558
United States, North Carolina
Raleigh, North Carolina, United States, 27607
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sylvania, Ohio, United States, 43560
United States, Texas
Fort Worth, Texas, United States, 76132
Houston, Texas, United States, 77084
United States, Wisconsin
Madison, Wisconsin, United States, 53792-9988
Sponsors and Collaborators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT00659750     History of Changes
Other Study ID Numbers: BY9010/M1-402
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: October 2016
Keywords provided by AstraZeneca:
Perennial Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents