CompletedNCT01010971Updated Jun 13, 2012Results posted

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 interventional study of Ciclesonide HFA 160 μg and Ciclesonide HFA 80 μg in Seasonal Allergic Rhinitis, sponsored by Sumitomo Pharma America, Inc.. Completed at 7 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-06-13.

Sponsored by Sumitomo Pharma America, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 671
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study 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). 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.

Conditions studied

Seasonal Allergic Rhinitis

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Keywords

Mountain Cedar

In context

Rhinitis

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

This study's enrollment of 671 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

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

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 671 participants (actual)

Study arms

Experimental
Ciclesonide HFA Nasal Aerosol 160 μg
160 μg once daily
Drug: Ciclesonide HFA 160 μg
Experimental
Ciclesonide HFA Nasal Aerosol 80 μg
80 μg once daily
Drug: Ciclesonide HFA 80 μg
Placebo comparator
Placebo
Placebo
Drug: Placebo

Interventions

DrugCiclesonide HFA 160 μg
Ciclesonide HFA Nasal Aerosol 160 μg once daily
DrugCiclesonide HFA 80 μg
Ciclesonide HFA Nasal Aerosol 80 μg once daily
DrugPlacebo
Placebo HFA Nasal Aerosol once daily

What researchers measure

Primary outcomes

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.
Time frame: Week 0-2

Secondary outcomes

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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2
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.
Time frame: Week 0-2

Results

Posted Jun 8, 2012

Limitations and caveats

This study was not designed or powered for a comparison of the 80mcg dose with the 160mcg dose therefore no statistical comparisons were planned between the two active groups. Publication references to 74 and 148mcg are equivalent to 80 and 160mcg

Participant flow

Participant flow — Overall Study
Milestone	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Started	225	226	220
Completed	222	218	207
Not completed	3	8	13
Withdrew: Adverse event	2	4	3
Withdrew: Withdrawal by subject	0	2	5
Withdrew: Lost to follow-up	0	2	3
Withdrew: Other	1	0	2

Outcome measures

PrimaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · Units on a scale

Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.
Units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.	-1.74 ± 0.15	-1.75 ± 0.15	-0.72 ± 0.16

Statistical analysis

Ciclesonide HFA Nasal Aerosol 160 μg vs Placebo · ANCOVA · p = <0.0001 (The p-value from primary outcome was adjusted at alpha=0.025.) · Mean difference (final values): 1.02 · 95% CI 0.59 to 1.45
Ciclesonide HFA Nasal Aerosol 80 μg vs Placebo · ANCOVA · p = <0.0001 (The p-value from primary outcome was adjusted at alpha=0.025.) · Mean difference (final values): 1.04 · 95% CI 0.61 to 1.46

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.	-0.36 ± 0.04	-0.36 ± 0.04	-0.18 ± 0.04

Statistical analysis

Ciclesonide HFA Nasal Aerosol 160 μg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.18 · 95% CI 0.07 to 0.29
Ciclesonide HFA Nasal Aerosol 80 μg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 0.19 · 95% CI 0.08 to 0.29

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

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
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
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	-1.21 ± 0.13	-1.40 ± 0.13	-0.88 ± 0.13

Statistical analysis

Ciclesonide HFA Nasal Aerosol 160 μg vs Placebo · ANCOVA · p = 0.1444 (Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons) · Mean difference (final values): 0.34 · 95% CI -0.03 to 0.71
Ciclesonide HFA Nasal Aerosol 80 μg vs Placebo · ANCOVA · p = 0.0124 (Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons) · Mean difference (final values): 0.52 · 95% CI 0.15 to 0.89

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

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
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
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	-1.41 ± 0.12	-1.44 ± 0.11	-0.79 ± 0.12

Statistical analysis

Ciclesonide HFA Nasal Aerosol 160 μg vs Placebo · ANCOVA · p = 0.0124 (Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons) · Mean difference (final values): 0.62 · 95% CI 0.30 to 0.94
Ciclesonide HFA Nasal Aerosol 80 μg vs Placebo · ANCOVA · Mean difference (final values): 0.64 · 95% CI 0.33 to 0.95

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.	-1.77 ± 0.15	-1.84 ± 0.15	-0.77 ± 0.16

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.	-1.70 ± 0.16	-1.67 ± 0.16	-0.66 ± 0.16

SecondaryChange 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.

Time frame:: Week0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.	-1.56 ± 0.15	-1.60 ± 0.15	-0.71 ± 0.15

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.	-1.46 ± 0.16	-1.56 ± 0.15	-0.64 ± 0.16

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0	-1.24 ± 0.14	-1.41 ± 0.14	-0.88 ± 0.13

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0	-1.21 ± 0.14	-1.39 ± 0.14	-0.88 ± 0.14

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.	-1.12 ± 0.14	-1.24 ± 0.14	-0.72 ± 0.14

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.	-1.14 ± 0.15	-1.20 ± 0.15	-0.74 ± 0.15

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

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.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
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.	-1.13 ± 0.14	-1.21 ± 0.14	-0.72 ± 0.14

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Sneezing	-0.36 ± 0.04	-0.40 ± 0.04	-0.14 ± 0.04
Runny Nose	-0.40 ± 0.04	-0.45 ± 0.04	-0.18 ± 0.04
Nasal Itching	-0.45 ± 0.04	-0.39 ± 0.04	-0.21 ± 0.04
Nasal Congestion	-0.35 ± 0.04	-0.37 ± 0.04	-0.18 ± 0.04

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Sneezing	-0.35 ± 0.04	-0.40 ± 0.04	-0.14 ± 0.04
Runny Nose	-0.36 ± 0.04	-0.42 ± 0.04	-0.16 ± 0.04
Nasal Itching	-0.39 ± 0.04	-0.37 ± 0.04	-0.16 ± 0.04
Nasal Congestion	-0.36 ± 0.04	-0.36 ± 0.04	-0.18 ± 0.04

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Sneezing	-0.35 ± 0.04	-0.40 ± 0.04	-0.14 ± 0.04
Runny Nose	-0.38 ± 0.04	-0.43 ± 0.04	-0.17 ± 0.04
Nasal Itching	-0.42 ± 0.04	-0.38 ± 0.04	-0.19 ± 0.04
Nasal Congestion	-0.36 ± 0.04	-0.36 ± 0.04	-0.18 ± 0.04

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
sneezing	-0.47 ± 0.04	-0.51 ± 0.04	-0.18 ± 0.05
runny nose	-0.44 ± 0.04	-0.51 ± 0.04	-0.21 ± 0.04
nasal itching	-0.47 ± 0.04	-0.43 ± 0.04	-0.20 ± 0.04
nasal congestion	-0.40 ± 0.04	-0.38 ± 0.04	-0.18 ± 0.04

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Sneezing	-0.43 ± 0.04	-0.43 ± 0.04	-0.14 ± 0.04
Runny Nose	-0.43 ± 0.04	-0.45 ± 0.04	-0.16 ± 0.05
Nasal Itching	-0.45 ± 0.04	-0.39 ± 0.04	-0.16 ± 0.04
Nasal Congestion	-0.39 ± 0.04	-0.40 ± 0.04	-0.20 ± 0.04

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Sneezing	-0.45 ± 0.04	-0.47 ± 0.04	-0.16 ± 0.04
Runny Nose	-0.44 ± 0.04	-0.41 ± 0.04	-0.18 ± 0.04
Nasal Itching	-0.44 ± 0.04	-0.41 ± 0.04	-0.18 ± 0.04
Nasal Congestion	-0.39 ± 0.04	-0.39 ± 0.04	-0.19 ± 0.04

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.37 ± 0.05	-0.39 ± 0.05	-0.24 ± 0.05
redness of eyes	-0.38 ± 0.05	-0.38 ± 0.05	-0.21 ± 0.05
tearing eyes	-0.37 ± 0.05	-0.47 ± 0.05	-0.27 ± 0.05

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.38 ± 0.05	-0.37 ± 0.05	-0.25 ± 0.05
redness of eyes	-0.39 ± 0.05	-0.37 ± 0.05	-0.27 ± 0.05
tearing eyes	-0.38 ± 0.05	-0.45 ± 0.05	-0.22 ± 0.06

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

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.37 ± 0.05	-0.38 ± 0.05	-0.24 ± 0.05
redness of eyes	-0.39 ± 0.05	-0.38 ± 0.05	-0.24 ± 0.05
tearing eyes	-0.37 ± 0.05	-0.46 ± 0.05	-0.24 ± 0.05

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · participants

Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0
participants	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.41 ± 0.05	-0.45 ± 0.05	-0.31 ± 0.05
redness of eyes	-0.41 ± 0.05	-0.42 ± 0.05	-0.25 ± 0.05
tearing eyes	-0.42 ± 0.05	-0.53 ± 0.05	-0.33 ± 0.05

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · participants

Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
participants	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.42 ± 0.05	-0.43 ± 0.05	-0.28 ± 0.05
redness of eyes	-0.39 ± 0.05	-0.42 ± 0.05	-0.28 ± 0.05
tearing eyes	-0.40 ± 0.05	-0.54 ± 0.05	-0.32 ± 0.05

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
itching eyes	-0.42 ± 0.05	-0.44 ± 0.05	-0.29 ± 0.05
redness of eyes	-0.39 ± 0.05	-0.42 ± 0.05	-0.27 ± 0.05
tearing eyes	-0.41 ± 0.05	-0.53 ± 0.05	-0.32 ± 0.05

SecondaryChange 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · units on a scale

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
units on a scale	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
Overall Score	-1.41 ± 0.12	-1.44 ± 0.11	-0.79 ± 0.12
Domain 1: Activities	-1.39 ± 0.13	-1.34 ± 0.12	-0.70 ± 0.13
Domain 2: Sleep	-1.49 ± 0.14	-1.60 ± 0.13	-0.83 ± 0.14
Domain 3: Non-Nose/Eye Symptoms	-1.33 ± 0.12	-1.21 ± 0.11	-0.67 ± 0.12
Domain 4: Practical Problems	-1.62 ± 0.13	-1.64 ± 0.12	-0.91 ± 0.13
Domain 5: Nasal Symptoms	-1.52 ± 0.13	-1.61 ± 0.12	-0.83 ± 0.13
Domain 6: Eye Symptoms	-1.25 ± 0.13	-1.25 ± 0.12	-0.81 ± 0.13
Domain 7: Emotional	-1.36 ± 0.13	-1.36 ± 0.12	-0.82 ± 0.13

SecondaryTime 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.

Time frame:: Week 0-2
Reported as:: Least squares mean · Days

Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.
Days	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg
Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.	7 ± 0.18	8 ± 0.19

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ciclesonide HFA Nasal Aerosol 160 μg	—	0/225 (0%)	6/225 (2.7%)
Ciclesonide HFA Nasal Aerosol 80 μg	—	0/226 (0%)	3/226 (1.3%)
Placebo	—	0/220 (0%)	4/220 (1.8%)

Most frequent other events

Most frequent other events
Event	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo
EpistaxisRespiratory, thoracic and mediastinal disorders	6/225	3/226	4/220

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
<=18 years	20	21	10	51
Between 18 and 65 years	198	194	202	594
>=65 years	7	11	8	26

Age Continuous
Age Continuous(years)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
Mean	40.4 ± 14.4	39.8 ± 14.7	41.0 ± 13.5	40.4 ± 14.2

Sex: Female, Male
Sex: Female, Male(Participants)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
Female	129	140	129	398
Male	96	86	91	273

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
Hispanic or Latino	98 ± 43.6	89 ± 39.4	100 ± 45.5	287 ± 42.8
Not Hispanic or Latino	127 ± 56.4	137 ± 60.6	120 ± 54.5	384 ± 57.2
Unknown or Not Reported	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
White/Caucasian	207	191	191	589
Black/African American	13	26	23	62
Asian	3	7	5	15
American Indian or Alaska Native	0	0	1	1
Native Hawaiin or Other Pacific Islander	1	1	0	2
Multiple	0	1	0	1
Other	1	0	0	1

Baseline Reflective Total Nasal Symptom Score (rTNSS)
Baseline Reflective Total Nasal Symptom Score (rTNSS)(units on a scale)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
AM	9.33 ± 1.78	9.47 ± 1.80	9.34 ± 1.76	9.38 ± 1.78
PM	9.20 ± 1.97	9.21 ± 2.11	9.21 ± 1.92	9.21 ± 2.00
AM and PM	9.26 ± 1.80	9.34 ± 1.88	9.28 ± 1.77	9.29 ± 1.82

Baseline Instantaneous Total Nasal Symptom Score (iTNSS)
Baseline Instantaneous Total Nasal Symptom Score (iTNSS)(units on a scale)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
AM	8.77 ± 2.10	8.73 ± 2.18	8.69 ± 2.19	8.73 ± 2.15
PM	8.51 ± 2.29	8.49 ± 2.35	8.36 ± 2.38	8.45 ± 2.34
AM and PM	8.64 ± 2.14	8.60 ± 2.15	8.53 ± 2.21	8.59 ± 2.16

Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with rTOSS ≥5.0
Baseline Baseline Reflective Ocular Symptom Score (rTOSS) in Subjects with rTOSS ≥5.0(units on a scale)	Ciclesonide HFA Nasal Aerosol 160 μg	Ciclesonide HFA Nasal Aerosol 80 μg	Placebo	Total
AM	7.09 ± 1.24	7.17 ± 1.24	6.99 ± 1.21	7.09 ± 1.23
PM	7.00 ± 1.30	7.10 ± 1.25	6.94 ± 1.30	7.01 ± 1.28
AM and PM	7.04 ± 1.22	7.13 ± 1.19	6.97 ± 1.19	7.05 ± 1.20

6 further baseline measures are reported on the registry.

Study locations

7 sites

Allergy and Asthma Associates
Austin, Texas 78731, United States
Sinus Clinical Research LLC
Austin, Texas 78759, United States
Central Texas Health Research Corporation
New Braunfels, Texas 78130, United States
Biogenics Research Institute
San Antonio, Texas 78229, United States
Southwest Allergy and Asthma Research Center, Pa
San Antonio, Texas 78229, United States
Sylvana Research
San Antonio, Texas 78229, United States
San Antonio, Texas 78229, United States

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01010971
Lead sponsor: Sumitomo Pharma America, Inc.
Responsible party: Sponsor
First posted: Nov 10, 2009
Start date: Dec 2009
Primary completion: Feb 2010
Completion: Feb 2010
Results posted: Jun 8, 2012
Last update: Jun 13, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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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

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