Perennial Allergic Rhinitis
Conditions
Keywords
perennial allergic rhinitis, PAR
Brief summary
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an Internasal Corticosteroid (INCS)
Detailed description
This is an open-label, randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate the psychometric properties of a novel-patient administered assessment of treatment satisfaction with and preference of an INCS. Subjects will be randomized to 1 of 2 treatment sequences: Sequence 1: Treatment Period 1 = ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily; Treatment Period 2 = mometasone nasal inhalation 200 μg once daily Sequence 2: Treatment Period 1 = mometasone nasal inhalation 200 μg once daily; Treatment Period 2 = ciclesonide HFA nasal aerosol 80 μg once daily Total study participation will be approximately 8 weeks including a 3-week screening/baseline phase, a 1-week treatment period, a 1- to 2- week washout phase between treatments, a second 1-week treatment period consisting of the alternate treatment, and an additional 1-week follow up period after the last dose of study drug to assess safety. Subjects are required to continue to meet eligibility criteria for the second treatment period. Nasal symptoms will be evaluated daily from 7 days prior to the first dose of study drug in Treatment Period 1 through the last dose of study drug in Treatment Period 2. The Allergic Rhinitis Satisfaction and Preference (ARTSP) and other Modules from the Phase V® e-Health Outcomes Information System (Phase V Technologies, Wellesley MA) will be completed two times during each treatment period (before the first dose and on the day after the last dose) via the internet at the clinical site. Patient preference will be evaluated at the day after last dose only.
Interventions
DRUGciclesonide hydrofluoroalkane (HFA) nasal aerosol
ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week.
DRUGmometasone nasal inhalation
mometasone nasal inhalation 200 μg once daily for one week
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Give written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * Male or female 12 years and older at screening * 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, clinical laboratory results, and medical history. * A history of PAR to a relevant perennial allergen (house dust mites, cockroach, molds, animal dander) for a minimum of two years immediately preceding screening. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past, and require treatment with an INCS throughout the entire study period. * At least one treatment for PAR during the 6 months prior to expected randomization was a nasal spray. * A demonstrated sensitivity to at least one allergen known to induce PAR (house dust mites, animal dander, cockroach, and molds) based on a documented result with a standard skin-prick test either within 90 days prior to or at screening. A positive test is defined as a wheal diameter at least 3 mm larger than the negative control wheal for the skin-prick test. The subject's positive test for the allergen must be consistent with the medical history of PAR and the allergen must be present in the subject's environment throughout the study. * Based upon subject's medical history, in the investigator's judgment, the subject is unlikely to have a seasonal allergy exacerbation during the study. * Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test at screening. 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: a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for 30 days following completion of study participation. b.Barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study. c.Abstinence. * The subject must possess a degree of understanding of written English, in the opinion of the investigator that enables them to complete the Phase V® Technologies Inc. (PVT) Modules.
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; or nasal ulcers or perforations. Surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to screening. * Presently has nasal jewelry, has had a nasal piercing, or a history of nasal surgery (e.g., rhinoplasty, septoplasty) or trauma to the nasal cavity. * Subject is, in the investigator's judgment, having a seasonal exacerbation at screening. * Participation in any investigational drug trial within the 30 days preceding screening or planned participation in another investigational drug trial at any time during this study. * A known hypersensitivity to any corticosteroid or any of the components in the formulations of ciclesonide or Nasonex. * History of a respiratory infection or disorder (including, but not limited to, bronchitis, pneumonia, influenza, severe acute respiratory syndrome \[SARS\]) within the 14 days preceding screening. * History of alcohol or drug abuse within 2 years preceding screening. * History of a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (e.g., theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to three uses per week) of inhaled short-acting beta-agonists is acceptable. Use of short-acting beta-agonists for exercise-induced bronchospasm is allowed. * Expected use of any disallowed medications during the study period. * Expected initiation of immunotherapy during the study period or planned dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to screening and use of a stable (maintenance) dose (30 days or more) may be considered for inclusion. * Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding screening. * Expected 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 site employees and/or their immediate relatives who reside in the same household. * Study participation by more than one subject from the same household. * 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, e.g., glaucoma or posterior subcapsular cataracts; any systemic infection; hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism) disease; gastrointestinal disease; malignancy (excluding basal cell carcinoma); current neuropsychological condition with or without drug therapy * Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with completion of the assessments as written.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Day 1 (Pre-treatment) through Day 7 Treatment Period 2 | Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses \[Cronbach's alpha (raw and standardized) coefficients were calculated\]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability. |
| Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Day 1 (Pre-treatment) through Day 7 Treatment Period 1 | Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). |
| Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Day 1 (pre-treatment) through Day 7 Treatment Period 1 | Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). |
| Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Day 1 (pre-treatment) through Day 7 Treatment Period 2 | Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). |
| Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Day 1 (Pre-treatment) through Day 29 | Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are small(0.2), medium (0.5), and large (0.8). Between group SES indicates the magnitude of treatment differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). |
| Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | Day 1 (Pre-treatment) through Day 29 | Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables correlates with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide HFA Followed by Mometasone ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered. | 94 |
| Mometasone Followed by Ciclesonide HFA mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered | 91 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Other Reason | 4 | 2 |
| Overall Study | Protocol Violation | 5 | 5 |
Baseline characteristics
| Characteristic | Ciclesonide HFA Followed by Mometasone | Mometasone Followed by Ciclesonide HFA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 78 Participants | 159 Participants |
| Age Continuous | 39.1 years STANDARD_DEVIATION 15.1 | 37.5 years STANDARD_DEVIATION 14.6 | 38.3 years STANDARD_DEVIATION 14.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 22 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 69 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 80 Participants | 77 Participants | 157 Participants |
| Sex: Female, Male Female | 65 Participants | 56 Participants | 121 Participants |
| Sex: Female, Male Male | 29 Participants | 35 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 175 | 4 / 176 |
| serious Total, serious adverse events | 0 / 175 | 0 / 176 |
Outcome results
Primary
Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)
Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).
Time frame: Day 1 (Pre-treatment) through Day 7 Treatment Period 1
Population: Baseline rTNSS was partitioned into tertile ranges and patients were assigned to Low (3.00 - 7.17; n = 62), Medium (7.25 - 9.25; n = 61), or High (9.33 - 12.00; n = 62) symptom groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Burden | 77.818 scores on a scale | Standard Error 2.606 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Role Limitation | 87.141 scores on a scale | Standard Error 2.322 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Management | 80.949 scores on a scale | Standard Error 2.094 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Perceived Relief | 56.066 scores on a scale | Standard Error 2.435 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Overall Satisfaction | 73.189 scores on a scale | Standard Error 1.927 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Difficulty | 85.940 scores on a scale | Standard Error 2.254 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Adaptation | 60.764 scores on a scale | Standard Error 2.4575 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Sensory Impact | 67.934 scores on a scale | Standard Error 2.66 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Hassle | 63.361 scores on a scale | Standard Error 3.725 |
| Average Cronbach's Alpha (Raw) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Interference | 78.726 scores on a scale | Standard Error 3.186 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Adaptation | 59.491 scores on a scale | Standard Error 2.455 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Difficulty | 78.890 scores on a scale | Standard Error 2.235 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Burden | 76.109 scores on a scale | Standard Error 2.585 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Management | 81.771 scores on a scale | Standard Error 2.077 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Role Limitation | 83.528 scores on a scale | Standard Error 2.303 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Perceived Relief | 55.457 scores on a scale | Standard Error 2.415 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Hassle | 49.839 scores on a scale | Standard Error 3.695 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Sensory Impact | 61.452 scores on a scale | Standard Error 2.638 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Overall Satisfaction | 68.607 scores on a scale | Standard Error 1.911 |
| Average Cronbach's Alpha (Standardized) Coefficients | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Interference | 70.931 scores on a scale | Standard Error 3.16 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Overall Satisfaction | 59.407 scores on a scale | Standard Error 1.911 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Interference | 59.018 scores on a scale | Standard Error 3.16 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Adaptation | 53.455 scores on a scale | Standard Error 2.455 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Role Limitation | 73.269 scores on a scale | Standard Error 2.303 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Difficulty | 71.676 scores on a scale | Standard Error 2.235 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Sensory Impact | 53.742 scores on a scale | Standard Error 2.638 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Hassle | 40.726 scores on a scale | Standard Error 3.695 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Burden | 60.534 scores on a scale | Standard Error 2.585 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Regimen Management | 72.192 scores on a scale | Standard Error 2.077 |
| High Symptoms | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) | Perceived Relief | 50.054 scores on a scale | Standard Error 2.415 |
Primary
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables correlates with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors.
Time frame: Day 1 (Pre-treatment) through Day 29
Population: Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for convenience | 0.766 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for use in public | 0.762 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | if both were the same price | 0.433 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for ease of use | 0.764 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for taste | 0.756 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | fewer problems with medicaton running out nose | 0.722 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for number of sprays per dose | 0.713 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for flexibility in daily activities | 0.712 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for smell | 0.706 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | fewer problems w/ medication dripping down throat | 0.666 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for longer relief | 0.230 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for symptom relief | 0.243 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for faster relief | 0.283 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for better feeling about your appearance | 0.539 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for fewer problems with irritation to your nose | 0.509 factor loadings |
| Average Cronbach's Alpha (Raw) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for how is makes your nose feel | 0.501 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for how is makes your nose feel | 0.571 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for ease of use | 0.450 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for smell | 0.360 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for faster relief | 0.802 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | if both were the same price | 0.773 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for convenience | 0.433 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | fewer problems w/ medication dripping down throat | 0.234 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for use in public | 0.270 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for fewer problems with irritation to your nose | 0.587 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for taste | 0.142 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for longer relief | 0.876 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | fewer problems with medicaton running out nose | 0.324 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for better feeling about your appearance | 0.678 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for number of sprays per dose | 0.331 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for symptom relief | 0.875 factor loadings |
| Average Cronbach's Alpha (Standardized) Coefficients | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | for flexibility in daily activities | 0.560 factor loadings |
Primary
Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).
Time frame: Day 1 (pre-treatment) through Day 7 Treatment Period 1
Population: The rTNSS total period 1 change scores were partitioned into tertile ranges to form three groups: Low Change (-1.04 - -4.93; n = 60), Medium Change (-2.49 - -1.05; n = 62), and High Change (-7.57 - -2.50; n = 61).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 15.469 scores on a scale | Standard Error 2.223 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | -1.083 scores on a scale | Standard Error 2.475 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 9.764 scores on a scale | Standard Error 1.121 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 8.042 scores on a scale | Standard Error 1.583 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | 12.667 scores on a scale | Standard Error 2.27 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | 7.201 scores on a scale | Standard Error 1.314 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | 10.492 scores on a scale | Standard Error 2.458 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | 11.250 scores on a scale | Standard Error 3.114 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | -2.917 scores on a scale | Standard Error 3.296 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | 1.121 scores on a scale | Standard Error 2.531 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | 15.836 scores on a scale | Standard Error 2.496 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | 12.121 scores on a scale | Standard Error 2.469 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 9.348 scores on a scale | Standard Error 1.82 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | 8.280 scores on a scale | Standard Error 2.84 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | 11.906 scores on a scale | Standard Error 1.479 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 10.512 scores on a scale | Standard Error 1.721 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | 3.760 scores on a scale | Standard Error 2.579 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | 13.226 scores on a scale | Standard Error 2.702 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | 17.742 scores on a scale | Standard Error 2.723 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 16.331 scores on a scale | Standard Error 2.321 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | 14.735 scores on a scale | Standard Error 1.799 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | 13.333 scores on a scale | Standard Error 3.199 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 12.440 scores on a scale | Standard Error 1.732 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | 2.083 scores on a scale | Standard Error 2.71 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | 19.475 scores on a scale | Standard Error 2.959 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | 26.475 scores on a scale | Standard Error 3.66 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 16.701 scores on a scale | Standard Error 2.809 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 9.027 scores on a scale | Standard Error 1.587 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | 12.705 scores on a scale | Standard Error 3.706 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | 20.380 scores on a scale | Standard Error 2.922 |
Primary
Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (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. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).
Time frame: Day 1 (pre-treatment) through Day 7 Treatment Period 2
Population: The rTNSS total period 2 change scores were partitioned into tertile ranges to form three groups: Low Change (-0.70 - -1.85; n = 55), Medium Change (-2.08 - -1.74; n = 56), or High Change (-6.57 - -2.14; n = 55).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | -3.407 scores on a scale | Standard Error 3.33 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | -0.648 scores on a scale | Standard Error 3.748 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 1.852 scores on a scale | Standard Error 1.321 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 0.2521 scores on a scale | Standard Error 1.79 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | -6.512 scores on a scale | Standard Error 4.28 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | -2.510 scores on a scale | Standard Error 1.818 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | .8838 scores on a scale | Standard Error 2.739 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | -8.462 scores on a scale | Standard Error 1.159 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 1.075 scores on a scale | Standard Error 1.16 |
| Average Cronbach's Alpha (Raw) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | -7.620 scores on a scale | Standard Error 2.61 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 1.265 scores on a scale | Standard Error 2.156 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 6.079 scores on a scale | Standard Error 1.774 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | -2.381 scores on a scale | Standard Error 3.167 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | 2.337 scores on a scale | Standard Error 1.832 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | 7.914 scores on a scale | Standard Error 2.195 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | -3.751 scores on a scale | Standard Error 2.757 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | -0.500 scores on a scale | Standard Error 3.113 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | -3.761 scores on a scale | Standard Error 3.447 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | 8.036 scores on a scale | Standard Error 3.052 |
| Average Cronbach's Alpha (Standardized) Coefficients | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 8.147 scores on a scale | Standard Error 2.121 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Hassle | 10.273 scores on a scale | Standard Error 3.044 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Management | 1.524 scores on a scale | Standard Error 2.029 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Adaptation | 4.242 scores on a scale | Standard Error 3.509 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Sensory Impact | 3.200 scores on a scale | Standard Error 3.172 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Perceived Relief | 8.424 scores on a scale | Standard Error 2.928 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Role Limitation | 4.688 scores on a scale | Standard Error 1.465 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Regimen Difficulty | .309 scores on a scale | Standard Error 2.469 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Overall Satisfaction | 4.875 scores on a scale | Standard Error 1.436 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Burden | 4.602 scores on a scale | Standard Error 1.144 |
| High Symptoms | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) | Interference | 6.612 scores on a scale | Standard Error 1.782 |
Primary
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are small(0.2), medium (0.5), and large (0.8). Between group SES indicates the magnitude of treatment differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).
Time frame: Day 1 (Pre-treatment) through Day 29
Population: Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Adaptation | 0.057 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Difficulty | -0.057 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Interference | 0.551 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Role Limitation | 0.722 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Sensory Impact | 0.720 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Hassle | 0.466 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Burden | 0.898 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Management | 0.656 standard effect sizes |
| Average Cronbach's Alpha (Raw) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Perceived Relief | -0.114 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Role Limitation | 0.920 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Sensory Impact | 0.843 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Hassle | 0.926 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Perceived Relief | 0.439 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Difficulty | 0.098 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Management | 0.728 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Interference | 0.893 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Burden | 0.761 standard effect sizes |
| Average Cronbach's Alpha (Standardized) Coefficients | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Adaptation | 0.534 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Management | 0.076 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Difficulty | 0.157 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Burden | 0.064 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Hassle | 0.597 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Sensory Impact | 0.326 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Regimen Adaptation | 0.553 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Role Limitation | 0.198 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Perceived Relief | 0.591 standard effect sizes |
| High Symptoms | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Interference | 0.474 standard effect sizes |
Primary
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics
Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses \[Cronbach's alpha (raw and standardized) coefficients were calculated\]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
Time frame: Day 1 (Pre-treatment) through Day 7 Treatment Period 2
Population: Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Hassle | 0.918 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Interference | 0.971 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Adaptation | 0.932 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Role Limitations | 0.939 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Sensory Impact | 0.889 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Difficulties | 0.722 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Burden | 0.937 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Management | 0.750 ratio of variance |
| Average Cronbach's Alpha (Raw) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Perceived Relief | 0.864 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Perceived Relief | 0.871 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Difficulties | 0.731 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Interference | 0.972 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Hassle | 0.928 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Adaptation | 0.932 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Regimen Management | 0.804 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Role Limitations | 0.944 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Burden | 0.938 ratio of variance |
| Average Cronbach's Alpha (Standardized) Coefficients | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Sensory Impact | 0.895 ratio of variance |