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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
185
ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week.
mometasone nasal inhalation 200 μg once daily for one week
Allergy and Asthma Associates of Southern California
Mission Viejo, California, United States
Allergy & Asthma Medical Group & Research Center A.P.C.
San Diego, California, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Minneappolis, Minnesota, United States
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
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
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).
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Princeton Center for Clinical Research
Skillman, New Jersey, United States
Sylvania Research Associates
San Antonio, Texas, United States
Time frame: Day 1 (pre-treatment) through Day 7 Treatment Period 1
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
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
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