AzTrials
AzTrials

Seasonal Allergic RhinitisPhase 3NCT01010971

Clinical Trial to Assess the Efficacy and Safety of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older

A Phase 3 study testing Ciclesonide HFA 160 μg and Ciclesonide HFA 80 μg in people with Seasonal Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
Ciclesonide HFA 160 μg and Ciclesonide HFA 80 μg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
671 participants
Where
7 sitesUnited States
Study dates
Dec 2009to Feb 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Give written informed consent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.
  • Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis). If any of the Hematology, Chemistries, or Urinalysis are not within the clinical laboratory's reference range, then the subject can be included only if the Investigator judges the deviations to be not clinically significant.
  • A history of SAR to Mountain Cedar for a minimum of two years immediately preceding the study Screening Visit. The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the Investigator's judgment (through exposure to allergen) is expected to require treatment throughout the entire study period.
  • A demonstrated sensitivity to Mountain Cedar known to induce SAR through a standard skin prick test administered at screening. A positive test is defined as a wheal diameter at least 5 mm larger than the control wheal (normal saline) for the skin prick test.
  • Subject, if female 65 years of age or younger, must have a negative serum pregnancy test. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study and will continue its use throughout the study and for thirty days following study participation; Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study; Abstinence.
  • Subject or parent/guardian must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and study coordinator as well as accurately complete both the AR diary and RQLQ(S).

Who cannot join

  • Female subject who is pregnant or lactating.
  • History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; nasal ulcers or perforations; or surgery and atrophic rhinitis or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit).
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit or planned participation in another investigational drug trial at any time during this trial.
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide.
  • History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit .
  • History of alcohol or drug abuse within two years preceding the Screening Visit.
Show all 27Show fewer
  • History of a positive test for HIV, hepatitis B or hepatitis C.
  • Plans to travel outside the study area (the known pollen area for the investigative site) for more than 24 hours during the Run-in period.
  • Plans to travel outside the study area (the known pollen area for the investigative site) for 2 or more consecutive days between Randomization Visit and the final Treatment Visit.
  • Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists is acceptable.
  • Use of any disallowed concomitant medications within the prescribed (per protocol) time period prior to the Screening Visit and expected use during treatment period.
  • Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit. 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.
  • 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.
  • Previous participation in an intranasal ciclesonide HFA nasal aerosol study.
  • Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit.
  • 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 screening and use of a stable (maintenance) dose during the study period may be considered for inclusion.
  • Study participation by clinical investigator site employees and/or their immediate relatives.
  • Study participation by more than one subject from the same household at the same time.
  • 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:
  • impaired hepatic function including alcohol-related liver disease or cirrhosis;
  • history of ocular disturbances eg, 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);
  • current neuropsychological condition with or without drug therapy.
  • Any condition that, in the judgement of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Allergy and Asthma Associates

    Austin, Texas, 78731

  • Sinus Clinical Research LLC

    Austin, Texas, 78759

  • Central Texas Health Research Corporation

    New Braunfels, Texas, 78130

  • Biogenics Research Institute

    San Antonio, Texas, 78229

  • Southwest Allergy and Asthma Research Center, Pa

    San Antonio, Texas, 78229

  • Sylvana Research

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol (160 μg Once Daily and 80 μg Once Daily) for the Treatment of Seasonal Allergic Rhinitis (SAR) to Mountain Cedar in Subjects 12 Years and Older

This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. This study will consist of a Screening Period, followed by a Single-Blind Placebo Run-in period. The Double-blind Treatment period (14±2 days) will begin at randomization/Day 1 and consist of an interim visit 7±1 days after randomization, and an End of Study (EOS)/Early Termination (ET) visit. All subjects will have either a telephone contact, or in some cases an in-clinic visit, 7±2 days after their last study visit. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Being tested
Ciclesonide HFA 160 μg, Ciclesonide HFA 80 μg, Placebo
Keywords
Mountain Cedar
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ciclesonide HFA 160 μgDrug

    Ciclesonide HFA Nasal Aerosol 160 μg once daily

  • Ciclesonide HFA 80 μgDrug

    Ciclesonide HFA Nasal Aerosol 80 μg once daily

  • PlaceboDrug

    Placebo HFA Nasal Aerosol once daily

Study groups in NCT01010971
Study groupRoleWhat they receive
Ciclesonide HFA Nasal Aerosol 160 μgExperimental160 μg once daily
Receives: Drug: Ciclesonide HFA 160 μg
Ciclesonide HFA Nasal Aerosol 80 μgExperimental80 μg once daily
Receives: Drug: Ciclesonide HFA 80 μg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

Secondary outcomes (26)

  1. Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  2. Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  3. Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

    RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.

    Measured: Week 0-2

  4. Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  5. Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  6. Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week0-2

  7. Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.

    TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  8. Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  9. Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  10. Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  11. Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  12. Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.

    TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  13. Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

    1. = mild
    2. = moderate
    3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  14. Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

    1. = mild
    2. = moderate
    3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  15. Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

    1. = mild
    2. = moderate
    3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  16. Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent (no sign/symptom evident);

    1. = mild
    2. = moderate
    3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  17. Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  18. Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.

    NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  19. Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  20. Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  21. Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  22. Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  23. Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  24. Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0

    OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

    0 = absent

    1. = mild
    2. = moderate
    3. = severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

    Measured: Week 0-2

  25. Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0

    RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.

    Measured: Week 0-2

  26. Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.

    The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.

    Measured: Week 0-2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01010971
Sponsor's protocol ID
060-634
Status last verified
Jun 2012
First submitted
6 Nov 2009
Last updated
13 Jun 2012
Data monitoring committee
No

Publications

  • Ratner PH, Andrews C, Martin B, Howland W, Desai SY, Huang H, Hinkle J, Bode F. A study of the efficacy and safety of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis from mountain cedar pollen. Allergy Asthma Proc. 2012 Jan-Feb;33(1):27-35. doi: 10.2500/aap.2012.33.3490.

    PubMed 22370531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciclesonide HFA 160 μg and Ciclesonide HFA 80 μg in people with Seasonal Allergic Rhinitis, run by Sumitomo Pharma America, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period. (time frame: Week 0-2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01010971, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in