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CompletedNCT00807053Updated Dec 5, 2016

Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)

A Phase 2 interventional study of Ciclesonide HFA and Ciclesonide HFA in Rhinitis, Allergic, Seasonal, sponsored by AstraZeneca. Completed at 31 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
480
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 HFA, applied as a nasal aerosol once daily, in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.

02

Conditions studied

  • Rhinitis, Allergic, Seasonal

Keywords

  • Seasonal Allergic Rhinitis
  • Ciclesonide
  • SAR
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 480 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 increases risk during the trial
  3. A history of SAR to relevant seasonal allergen for a minimum of two years immediately preceding the study season. The SAR 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 grass or tree pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result 12 months prior to screening is acceptable
  5. Female is of child-bearing 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 pregnancy test at the Screnning Visit (B0) as well as at last on-treatment (T2)
  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 (over a 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 (B0)
  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 (B0), 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 of HIV, hepatitis B or hepatitis C
  8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of ß-agonists and any controller drugs (e.g., theophylline, leukotriene antagonists, etc.; intermittent use (less than or equal to 3 uses per week) of inhaled short acting ß-agonists is acceptable
  9. Plans to travel outside the study area (the known pollen area for the investigative site) for two or more consecutive days OR 5 or more days total starting from 7 days prior to Randomization Visit (T0) until the final Treatment Visit (T2)
  10. 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.
  11. 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 (B0) AND is expected to continue throughout the trial.
  12. 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 (B0) AND use of a stable (maintenance) dose (30 days or more) may be considered for inclusion.
  13. Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
  14. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).
  15. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone or equivalent within 30 days prior to the Screening Visit (B0); use of a topical hydrocortisone or equivalent in any concentration covering greater than 20% of the body surface; or presence of an underlying condition (as judged by the investigator) that can reasonably be expected to require treatment with such preparations during the course of the study.
  16. Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to the Screening Visit (B0) AND use of a stable (maintenance) dose during the study period may be considered for inclusion.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
480 participants (actual)

Study arms

  • Active comparator
    1

    Ciclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily

    Drug: Ciclesonide HFA

  • Active comparator
    2

    Ciclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily

    Drug: Ciclesonide HFA

  • Active comparator
    3

    Ciclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily

    Drug: Ciclesonide HFA

  • Placebo comparator
    4

    Placebo

    Drug: Placebo

Interventions

  • DrugCiclesonide HFA

    75 mcg Ciclesonide HFA versus Placebo

  • DrugCiclesonide HFA

    150 mcg Ciclesonide HFA versus Placebo

  • DrugCiclesonide HFA

    300 mcg Ciclesonide HFA 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 the first two weeks of treatment

    Time frame: 2 weeks

Secondary outcomes

  1. Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment

    Time frame: 2 weeks

  2. Physician-assessed total nasal symptoms score (PNSS) over the treatment period

    Time frame: 4 weeks

  3. Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0

    Time frame: 4 weeks

07

Study locations

31 sites
  • Altana/Nycomed
    Mission Viejo, California 92691, United States
  • Altana/Nycomed
    Orange, California 92868, United States
  • Altana/Nycomed
    San Diego, California 92123, United States
  • Altana/Nycomed
    Colorado Springs, Colorado 80907, United States
  • Altana/Nycomed
    Denver, Colorado 80230, United States
  • Altana/Nycomed
    Gainsville, Georgia 30501, United States
  • Altana/Nycomed
    Savannah, Georgia 31406, United States
  • Altana/Nycomed
    Stockbridge, Georgia 30281, United States
  • Altana/Nycomed
    Indianapolis, Indiana 46208, United States
  • Altana/Nycomed
    Overland Park, Kansas 66210, United States
  • Altana/Nycomed
    Bethesda, Maryland 20814, United States
  • Altana/Nycomed
    Minneapolis, Minnesota 55402, United States
  • Altana/Nycomed
    St. Louis, Missouri 63141, United States
  • Altana/Nycomed
    Lincoln, Nebraska 68505, United States
  • Altana/Nycomed
    Papillion, Nebraska 68046, United States
  • Altana/Nycomed
    Skillman, New Jersey 08558, United States
  • Altana/Nycomed
    West Brick, New Jersey 08724, United States
  • Altana/Nycomed
    Raleigh, North Carolina 27607, United States
  • Altana/Nycomed
    Ashland, Oregon 97520, United States
  • Altana/Nycomed
    Medford, Oregon 97504, United States
  • Altana/Nycomed
    Portland, Oregon 97213, United States
  • Altana/Nycomed
    Blue Bell, Pennsylvania 19422, United States
  • Altana/Nycomed
    Pittsburgh, Pennsylvania 15241, United States
  • Altana/Nycomed
    Upland, Pennsylvania 19013, United States
  • Altana/Nycomed
    Charleston, South Carolina 29414, United States
  • Altana/Nycomed
    Austin, Texas 78750, United States
  • Altana/Nycomed
    New Braunfels, Texas 78130, United States
  • Altana/Nycomed
    San Antonio, Texas 78229, United States
  • Altana/Nycomed
    Draper, Utah 84020, United States
  • Altana/Nycomed
    Burke, Virginia 22015, United States
  • Altana/Nycomed
    Richmond, Virginia 23226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00807053
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 11, 2008
Start date
Apr 2007
Primary completion
Jun 2007
Completion
Jul 2007
Last update
Dec 5, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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