Trial · NCT01401465
Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
NCT01401465, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2013-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray. Trials, record NCT01401465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01401465
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray
- NCT number
- NCT01401465
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 327 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- ciclesonide, mometasone
- First posted
- 2011-07-25
- Last updated
- 2013-04-30
- Results first posted
- 2013-04-30
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items | End of Study - Day 43 | For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less "run out" of nose, Longer relief, Less "run down" of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide. |
| Primary | Change From Baseline in Regimen Attributes Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). |
| Secondary | Treatment Process Composite Preference Score | End of Study - Day 43 | The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less "Run out" of nose, Less "Run down" of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone. |
| Secondary | Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. | Averages over each two week treatment period | The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. |
| Secondary | Change From Baseline in the Treatment Functional Impact Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. |
| Secondary | Change From Baseline in the Regimen Acceptance Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Interference | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | This subscale evaluates the patient's assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | This subscale evaluates the patient's assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | This subscale evaluates the patient's assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). |
| Secondary | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | This subscale evaluates the patient's degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items | End of Study - Day 43 | Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication | scores on a scale | MEAN |
| PRIMARY | Change From Baseline in Regimen Attributes Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Process Composite Preference Score | End of Study - Day 43 | ITT | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. | Averages over each two week treatment period | Per Protocol (PP) Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Treatment Functional Impact Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Regimen Acceptance Composite Score | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Treatment Satisfaction Rating Scale: Interference | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties | Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 | ITT Population | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items | Ciclesonide Versus Mometasone | 68.3 | Standard Deviation 35.2 | scores on a scale | |
| Change From Baseline in Regimen Attributes Composite Score | Ciclesonide | 13.90 | Standard Error 1.36 | scores on a scale | |
| Change From Baseline in Regimen Attributes Composite Score | Mometasone | 4.88 | Standard Error 1.36 | scores on a scale | |
| Treatment Process Composite Preference Score | Ciclesonide | 74.087 | Standard Deviation 33.743 | scores on a scale | |
| Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. | Ciclesonide | -2.4 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. | Mometasone | -2.3 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in the Treatment Functional Impact Composite Score | Ciclesonide | 12.36 | Standard Error 14.7 | scores on scale | |
| Change From Baseline in the Treatment Functional Impact Composite Score | Mometasone | 9.70 | Standard Error 1.48 | scores on scale | |
| Change From Baseline in the Regimen Acceptance Composite Score | Ciclesonide | 7.34 | Standard Error 2.79 | scores on a scale | |
| Change From Baseline in the Regimen Acceptance Composite Score | Mometasone | 2.99 | Standard Error 2.79 | scores on a scale |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | CIC / MOM | 165 | |
| Treatment Period 1 | STARTED | MOM / CIC | 162 | |
| Treatment Period 1 | COMPLETED | CIC / MOM | 150 | |
| Treatment Period 1 | COMPLETED | MOM / CIC | 146 | |
| Treatment Period 1 | NOT COMPLETED | CIC / MOM | 15 | |
| Treatment Period 1 | NOT COMPLETED | MOM / CIC | 16 | |
| Washout | STARTED | CIC / MOM | 150 | |
| Washout | STARTED | MOM / CIC | 146 | |
| Washout | COMPLETED | CIC / MOM | 150 | |
| Washout | COMPLETED | MOM / CIC | 146 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events10
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 | Application site pain | General disorders | Ciclesonide | 19 | 311 | 19 |
| other | Application site pain | General disorders | Mometasone | 3 | 312 | 3 |
| other | Headache | Nervous system disorders | Ciclesonide | 7 | 311 | 8 |
| other | Headache | Nervous system disorders | Mometasone | 12 | 312 | 15 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Ciclesonide | 7 | 311 | 11 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Mometasone | 4 | 312 | 4 |
| serious | Chest Pain | General disorders | Ciclesonide | 0 | 311 | 0 |
| serious | Chest Pain | General disorders | Mometasone | 1 | 312 | 1 |
| serious | Completed Suicide | Psychiatric disorders | Ciclesonide | 0 | 311 | 0 |
| serious | Completed Suicide | Psychiatric disorders | Mometasone | 1 | 312 | 1 |
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 | 33 | 311 |
| Total, other adverse events | Mometasone | 19 | 312 |
| Total, serious adverse events | Ciclesonide | 0 | 311 |
| Total, serious adverse events | Mometasone | 2 | 312 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24169063 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ciclesonide vs Mometasone: The Number of Subjects Experiencing AEs | Trial comparisons |
| Ciclesonide vs Mometasone: The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation | Trial comparisons |
| Ciclesonide vs Mometasone: serious adverse events | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01401465
GET https://conductscience.org/api/trials/v1/NCT01401465/registered?page=2