Trial · NCT01451541
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
NCT01451541, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2014-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). Trials, record NCT01451541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01451541
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
- NCT number
- NCT01451541
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 848 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Perennial Allergic Rhinitis, PAR
- Interventions
- Ciclesonide nasal aerosol 37 mcg, ciclesonide nasal aerosol 74 mcg, Placebo
- First posted
- 2011-10-13
- Last updated
- 2014-05-06
- Results first posted
- 2014-05-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Weeks 0-6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. 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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. |
| Secondary | Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. 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. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement |
| Secondary | Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | Weeks 0 -12 | PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses. |
| Secondary | Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)] | Weeks 0 -6 | The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated. |
| Secondary | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 | |
| Secondary | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Weeks 0-6 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Weeks 0 -12 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment | Weeks 0 -6 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period | Weeks 0 -12 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)] | Weeks 0 -6 | The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication. | Number of Days | NUMBER |
| SECONDARY | Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 | participants | NUMBER | |
| SECONDARY | Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs | Weeks 0 -12 | percentage of subjects | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group227
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Placebo | -1.51 | Standard Error 0.130 | units on a scale | |
| The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Ciclesonide Nasal Aerosol 37mcg | -2.10 | Standard Error 0.130 | units on a scale | |
| The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment. | Ciclesonide Nasal Aerosol 74 mcg | -1.98 | Standard Error 0.131 | units on a scale | |
| Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Placebo | -1.29 | Standard Error 0.122 | units on a scale | |
| Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Ciclesonide Nasal Aerosol 37mcg | -1.77 | Standard Error 0.122 | units on a scale | |
| Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment | Ciclesonide Nasal Aerosol 74 mcg | -1.72 | Standard Error 0.123 | units on a scale | |
| Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Placebo | -0.39 | Standard Error 0.05 | units on a scale | |
| Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Ciclesonide Nasal Aerosol 37mcg | -0.51 | Standard Error 0.05 | units on a scale | |
| Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment | Ciclesonide Nasal Aerosol 74 mcg | -0.30 | Standard Error 0.054 | units on a scale | |
| Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period | Placebo | -1.92 | Standard Error 0.13 | units on a scale |
1 to 10 of 227Source ClinicalTrials.gov
See all 227 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 283 | |
| Overall Study | STARTED | Ciclesonide Nasal Aerosol 37mcg | 282 | |
| Overall Study | STARTED | Ciclesonide Nasal Aerosol 74 mcg | 281 | |
| Overall Study | COMPLETED | Placebo | 247 | |
| Overall Study | COMPLETED | Ciclesonide Nasal Aerosol 37mcg | 257 | |
| Overall Study | COMPLETED | Ciclesonide Nasal Aerosol 74 mcg | 254 | |
| Overall Study | NOT COMPLETED | Placebo | 36 | |
| Overall Study | NOT COMPLETED | Ciclesonide Nasal Aerosol 37mcg | 25 | |
| Overall Study | NOT COMPLETED | Ciclesonide Nasal Aerosol 74 mcg | 27 |
Source ClinicalTrials.gov
Adverse events33
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 | PYREXIA | General disorders | Placebo | 12 | 283 | 13 |
| other | PYREXIA | General disorders | Ciclesonide Nasal Aerosol 37mcg | 18 | 282 | 20 |
| other | PYREXIA | General disorders | Ciclesonide Nasal Aerosol 74 mcg | 17 | 281 | 17 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 18 | 283 | 20 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Ciclesonide Nasal Aerosol 37mcg | 24 | 282 | 25 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Ciclesonide Nasal Aerosol 74 mcg | 25 | 281 | 29 |
| other | HEADACHE | Nervous system disorders | Placebo | 25 | 283 | 42 |
| other | HEADACHE | Nervous system disorders | Ciclesonide Nasal Aerosol 37mcg | 31 | 282 | 44 |
| other | HEADACHE | Nervous system disorders | Ciclesonide Nasal Aerosol 74 mcg | 25 | 281 | 38 |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Placebo | 19 | 283 | 22 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Ciclesonide Nasal Aerosol 37mcg | ||
| Total, all-cause mortality | Ciclesonide Nasal Aerosol 74 mcg | ||
| Total, other adverse events | Placebo | 83 | 283 |
| Total, other adverse events | Ciclesonide Nasal Aerosol 37mcg | 95 | 282 |
| Total, other adverse events | Ciclesonide Nasal Aerosol 74 mcg | 85 | 281 |
| Total, serious adverse events | Placebo | 1 | 283 |
| Total, serious adverse events | Ciclesonide Nasal Aerosol 37mcg | 1 | 282 |
| Total, serious adverse events | Ciclesonide Nasal Aerosol 74 mcg | 2 | 281 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01451541
GET https://conductscience.org/api/trials/v1/NCT01451541/results?page=2