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CompletedNCT00659750Updated Dec 2, 2016

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

A Phase 3 interventional study of Ciclesonide and Placebo in Rhinitis, Allergic, Perennial, sponsored by AstraZeneca. Completed at 23 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2016-12-02.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
418
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rhinitis, Allergic, Perennial

Keywords

  • Perennial Allergic Rhinitis
  • Ciclesonide
  • PAR
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 418 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
418 participants (actual)

Study arms

  • Active comparator
    1

    Ciclesonide 200µg

    Drug: Ciclesonide

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugCiclesonide

    200µg Ciclesonide versus Placebo

  • DrugPlacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over 6 weeks of treatment.

    Time frame: 6 weeks

Secondary outcomes

  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

07

Study locations

23 sites
  • Altana/Nycomed
    Encinitas, California 92924, United States
  • Altana/Nycomed
    Long Beach, California 90806, United States
  • Altana/Nycomed
    Los Angeles, California 90025, United States
  • Altana/Nycomed
    Mission Viejo, California 92691, United States
  • Altana/Nycomed
    San Diego, California 92123, United States
  • Altana/Nycomed
    San Jose, California 95117, United States
  • Altana/Nycomed
    Colorado Springs, Colorado 80907, United States
  • Altana/Nycomed
    Denver, Colorado 80206, United States
  • Altana/Nycomed
    Denver, Colorado 80230, United States
  • Altana/Nycomed
    Jupiter, Florida 33458, United States
  • Altana/Nycomed
    Rockville, Maryland 20850, United States
  • Altana/Nycomed
    North Dartmouth, Massachusetts 02747, United States
  • Altana/Nycomed
    Minneapolis, Minnesota 55402, United States
  • Altana/Nycomed
    St. Louis, Missouri 63141, United States
  • Altana/Nycomed
    Missoula, Montana 59804, United States
  • Altana/Nycomed
    Brick, New Jersey 08724, United States
  • Altana/Nycomed
    Skillman, New Jersey 08558, United States
  • Altana/Nycomed
    Raleigh, North Carolina 27607, United States
  • Altana/Nycomed
    Winston-Salem, North Carolina 27103, United States
  • Altana/Nycomed
    Sylvania, Ohio 43560, United States
  • Altana/Nycomed
    Fort Worth, Texas 76132, United States
  • Altana/Nycomed
    Houston, Texas 77084, United States
  • Altana/Nycomed
    Madison, Wisconsin 53792-9988, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00659750
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Apr 16, 2008
Start date
Dec 2003
Primary completion
May 2004
Completion
Apr 2005
Last update
Dec 2, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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