NCT01010971 - 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 | Crick

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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: * 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.

Outcomes

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.

Time frame: Week 0-2

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

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

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

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

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes