Trial · NCT01287364
Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
NCT01287364, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis. Trials, record NCT01287364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01287364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Novel Questionnaire to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids for the Treatment of Allergic Rhinitis
- NCT number
- NCT01287364
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 185 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- ciclesonide hydrofluoroalkane (HFA) nasal aerosol, mometasone nasal inhalation
- First posted
- 2011-02-01
- Last updated
- 2012-11-02
- Results first posted
- 2012-10-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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). |
| 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) | 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). |
| 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) | 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). |
| Primary | 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). |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | ratio of variance | NUMBER |
| PRIMARY | 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 | 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. | scores on a scale | MEAN |
| 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) | Day 1 (pre-treatment) through Day 7 Treatment Period 1 | 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). | scores on a scale | MEAN |
| 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) | Day 1 (pre-treatment) through Day 7 Treatment Period 2 | 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). | scores on a scale | MEAN |
| PRIMARY | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) | Day 1 (Pre-treatment) through Day 29 | Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups. | standard effect sizes | NUMBER |
| PRIMARY | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales | Day 1 (Pre-treatment) through Day 29 | 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. | factor loadings | NUMBER |
Source ClinicalTrials.gov
Results by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Average Cronbach's Alpha (Raw) Coefficients | Interference | 0.971 | ratio of variance | |
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Average Cronbach's Alpha (Standardized) Coefficients | Interference | 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 | Average Cronbach's Alpha (Raw) Coefficients | Regimen Adaptation | 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 | Average Cronbach's Alpha (Standardized) Coefficients | Regimen Adaptation | 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 | Average Cronbach's Alpha (Raw) Coefficients | Role Limitations | 0.939 | ratio of variance | |
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Average Cronbach's Alpha (Standardized) Coefficients | Role Limitations | 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 | Average Cronbach's Alpha (Raw) Coefficients | Sensory Impact | 0.889 | ratio of variance | |
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Average Cronbach's Alpha (Standardized) Coefficients | Sensory Impact | 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 | Average Cronbach's Alpha (Raw) Coefficients | Regimen Difficulties | 0.722 | ratio of variance | |
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics | Average Cronbach's Alpha (Standardized) Coefficients | Regimen Difficulties | 0.731 | ratio of variance |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciclesonide HFA Followed by Mometasone | 94 | |
| Overall Study | STARTED | Mometasone Followed by Ciclesonide HFA | 91 | |
| Overall Study | COMPLETED | Ciclesonide HFA Followed by Mometasone | 85 | |
| Overall Study | COMPLETED | Mometasone Followed by Ciclesonide HFA | 81 | |
| Overall Study | NOT COMPLETED | Ciclesonide HFA Followed by Mometasone | 9 | |
| Overall Study | NOT COMPLETED | Mometasone Followed by Ciclesonide HFA | 10 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Instillation Site Discomfort | General disorders | Ciclesonide | 5 | 175 | 5 |
| other | Instillation Site Discomfort | General disorders | Mometasone | 0 | 176 | 0 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Ciclesonide | 4 | 175 | 4 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Mometasone | 1 | 176 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Ciclesonide | 7 | 175 | 7 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Mometasone | 3 | 176 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciclesonide | ||
| Total, all-cause mortality | Mometasone | ||
| Total, other adverse events | Ciclesonide | 16 | 175 |
| Total, other adverse events | Mometasone | 4 | 176 |
| Total, serious adverse events | Ciclesonide | 0 | 175 |
| Total, serious adverse events | Mometasone | 0 | 176 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ciclesonide vs Mometasone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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