Trial Outcomes & Findings for Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis (NCT NCT01287364)
NCT ID: NCT01287364
Last Updated: 2012-11-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
185 participants
Primary outcome timeframe
Day 1 (Pre-treatment) through Day 7 Treatment Period 2
Results posted on
2012-11-02
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
91
|
|
Overall Study
COMPLETED
|
85
|
81
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Protocol Violation
|
5
|
5
|
|
Overall Study
Other Reason
|
4
|
2
|
Baseline Characteristics
Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Ciclesonide HFA Followed by Mometasone
n=94 Participants
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.
|
Mometasone Followed by Ciclesonide HFA
n=91 Participants
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
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age Continuous
|
39.1 years
STANDARD_DEVIATION 15.1 • n=93 Participants
|
37.5 years
STANDARD_DEVIATION 14.6 • n=4 Participants
|
38.3 years
STANDARD_DEVIATION 14.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
80 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 2Population: 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.
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.
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=185 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=185 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
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
|
0.972 ratio of variance
|
—
|
|
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
|
0.932 ratio of variance
|
—
|
|
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
|
0.944 ratio of variance
|
—
|
|
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
|
0.895 ratio of variance
|
—
|
|
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
|
0.731 ratio of variance
|
—
|
|
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
|
0.928 ratio of variance
|
—
|
|
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
|
0.938 ratio of variance
|
—
|
|
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
|
0.804 ratio of variance
|
—
|
|
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
|
0.871 ratio of variance
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 1Population: 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.
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).
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=62 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=61 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
n=62 Participants
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
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
|
70.931 scores on a scale
Standard Error 3.160
|
59.018 scores on a scale
Standard Error 3.160
|
|
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
|
59.491 scores on a scale
Standard Error 2.455
|
53.455 scores on a scale
Standard Error 2.455
|
|
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
|
83.528 scores on a scale
Standard Error 2.303
|
73.269 scores on a scale
Standard Error 2.303
|
|
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
|
78.890 scores on a scale
Standard Error 2.235
|
71.676 scores on a scale
Standard Error 2.235
|
|
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 2.660
|
61.452 scores on a scale
Standard Error 2.638
|
53.742 scores on a scale
Standard Error 2.638
|
|
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
|
49.839 scores on a scale
Standard Error 3.695
|
40.726 scores on a scale
Standard Error 3.695
|
|
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
|
76.109 scores on a scale
Standard Error 2.585
|
60.534 scores on a scale
Standard Error 2.585
|
|
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
|
81.771 scores on a scale
Standard Error 2.077
|
72.192 scores on a scale
Standard Error 2.077
|
|
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
|
55.457 scores on a scale
Standard Error 2.415
|
50.054 scores on a scale
Standard Error 2.415
|
|
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
|
68.607 scores on a scale
Standard Error 1.911
|
59.407 scores on a scale
Standard Error 1.911
|
PRIMARY outcome
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 1Population: 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).
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).
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=60 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=62 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
n=61 Participants
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
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
|
15.836 scores on a scale
Standard Error 2.496
|
20.380 scores on a scale
Standard Error 2.922
|
|
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
|
12.121 scores on a scale
Standard Error 2.469
|
13.333 scores on a scale
Standard Error 3.199
|
|
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
|
10.512 scores on a scale
Standard Error 1.721
|
12.440 scores on a scale
Standard Error 1.732
|
|
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
|
3.760 scores on a scale
Standard Error 2.579
|
2.083 scores on a scale
Standard Error 2.710
|
|
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 2.270
|
13.226 scores on a scale
Standard Error 2.702
|
19.475 scores on a scale
Standard Error 2.959
|
|
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
|
17.742 scores on a scale
Standard Error 2.723
|
26.475 scores on a scale
Standard Error 3.660
|
|
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
|
16.331 scores on a scale
Standard Error 2.321
|
16.701 scores on a scale
Standard Error 2.809
|
|
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
|
9.348 scores on a scale
Standard Error 1.820
|
9.027 scores on a scale
Standard Error 1.587
|
|
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
|
8.280 scores on a scale
Standard Error 2.840
|
12.705 scores on a scale
Standard Error 3.706
|
|
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
|
11.906 scores on a scale
Standard Error 1.479
|
14.735 scores on a scale
Standard Error 1.799
|
PRIMARY outcome
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 2Population: 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).
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).
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=54 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=56 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
n=55 Participants
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
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
|
7.914 scores on a scale
Standard Error 2.195
|
6.612 scores on a scale
Standard Error 1.782
|
|
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
|
-3.761 scores on a scale
Standard Error 3.447
|
4.242 scores on a scale
Standard Error 3.509
|
|
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
|
6.079 scores on a scale
Standard Error 1.774
|
4.688 scores on a scale
Standard Error 1.465
|
|
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 2.610
|
-3.751 scores on a scale
Standard Error 2.757
|
.309 scores on a scale
Standard Error 2.469
|
|
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
|
-0.500 scores on a scale
Standard Error 3.113
|
3.200 scores on a scale
Standard Error 3.172
|
|
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
|
8.036 scores on a scale
Standard Error 3.052
|
10.273 scores on a scale
Standard Error 3.044
|
|
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
|
8.147 scores on a scale
Standard Error 2.121
|
4.602 scores on a scale
Standard Error 1.144
|
|
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 1.790
|
1.265 scores on a scale
Standard Error 2.156
|
1.524 scores on a scale
Standard Error 2.029
|
|
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 4.280
|
-2.381 scores on a scale
Standard Error 3.167
|
8.424 scores on a scale
Standard Error 2.928
|
|
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
|
2.337 scores on a scale
Standard Error 1.832
|
4.875 scores on a scale
Standard Error 1.436
|
PRIMARY outcome
Timeframe: Day 1 (Pre-treatment) through Day 29Population: Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.
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).
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=60 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=62 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
n=61 Participants
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Regimen Management
|
0.656 standard effect sizes
|
0.728 standard effect sizes
|
0.076 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Interference
|
0.551 standard effect sizes
|
0.893 standard effect sizes
|
0.474 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Regimen Adaptation
|
0.057 standard effect sizes
|
0.534 standard effect sizes
|
0.553 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Role Limitation
|
0.722 standard effect sizes
|
0.920 standard effect sizes
|
0.198 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Regimen Difficulty
|
-0.057 standard effect sizes
|
0.098 standard effect sizes
|
0.157 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Sensory Impact
|
0.720 standard effect sizes
|
0.843 standard effect sizes
|
0.326 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Hassle
|
0.466 standard effect sizes
|
0.926 standard effect sizes
|
0.597 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Burden
|
0.898 standard effect sizes
|
0.761 standard effect sizes
|
0.064 standard effect sizes
|
|
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
Perceived Relief
|
-0.114 standard effect sizes
|
0.439 standard effect sizes
|
0.591 standard effect sizes
|
PRIMARY outcome
Timeframe: Day 1 (Pre-treatment) through Day 29Population: 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.
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.
Outcome measures
| Measure |
Average Cronbach's Alpha (Raw) Coefficients
n=185 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
Average Cronbach's Alpha (Standardized) Coefficients
n=185 Participants
Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
|
High Symptoms
Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. 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 where: 0 = absent, 1 = mild, 2 = moderate, and 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.
|
|---|---|---|---|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for convenience
|
0.766 factor loadings
|
0.433 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for ease of use
|
0.764 factor loadings
|
0.450 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for use in public
|
0.762 factor loadings
|
0.270 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for taste
|
0.756 factor loadings
|
0.142 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
fewer problems with medicaton running out nose
|
0.722 factor loadings
|
0.324 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for number of sprays per dose
|
0.713 factor loadings
|
0.331 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for flexibility in daily activities
|
0.712 factor loadings
|
0.560 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for smell
|
0.706 factor loadings
|
0.360 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
fewer problems w/ medication dripping down throat
|
0.666 factor loadings
|
0.234 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for longer relief
|
0.230 factor loadings
|
0.876 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for symptom relief
|
0.243 factor loadings
|
0.875 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for faster relief
|
0.283 factor loadings
|
0.802 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
if both were the same price
|
0.433 factor loadings
|
0.773 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for better feeling about your appearance
|
0.539 factor loadings
|
0.678 factor loadings
|
—
|
|
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
|
0.587 factor loadings
|
—
|
|
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
for how is makes your nose feel
|
0.501 factor loadings
|
0.571 factor loadings
|
—
|
Adverse Events
Ciclesonide
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Mometasone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ciclesonide
n=175 participants at risk
ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
|
Mometasone
n=176 participants at risk
mometasone nasal inhalation 200 μg once daily pooled
|
|---|---|---|
|
General disorders
Instillation Site Discomfort
|
2.9%
5/175 • Number of events 5
|
0.00%
0/176
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.3%
4/175 • Number of events 4
|
0.57%
1/176 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
7/175 • Number of events 7
|
1.7%
3/176 • Number of events 3
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER