Trial · NCT00953147
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
NCT00953147, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2012-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older. Trials, record NCT00953147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953147
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
- NCT number
- NCT00953147
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,110 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Allergic Rhinitis, Perennial Allergic Rhinitis
- Interventions
- Ciclesonide HFA 80 mcg, Ciclesonide HFA 160 mcg, Placebo
- First posted
- 2009-08-06
- Last updated
- 2012-06-13
- Results first posted
- 2012-06-07
- Limitations and caveats
This study was not designed or powered for a comparison of the 80mcg dose with the 160mcg dose therefore no statistical comparisons were planned between the two active groups. Publication references to 74 and 148mcg are equivalent to 80 and 160mcg
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) 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, 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 Daily Subject-reported AM and PM Instantaneous TNSS (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 Subject-reported AM rTNSS 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, 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 Daily Subject-reported PM rTNSS 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, 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 Daily 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 Subject-reported PM 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 Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment | Weeks 0 - 6 | NSS is the assessment of the 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 Reflective NSS 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 Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment | Weeks 0-6 | NSS is the assessment of the 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 Reflective NSS 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 Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period. | Weeks 0-6 | NSS is the assessment of the 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 Reflective NSS 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 Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment | Weeks 0-6 | NSS is the assessment of the 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 Instantaneous NSS 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Weeks 0-6 | Intent to Treat Population. Not all participants analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment | Weeks 0 - 6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period. | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment | Weeks 0-6 | Intent to Treat Population. Not all subjects analyzed due to missing data. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Ciclesonide HFA 80 Mcg Once Daily | -1.97 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Ciclesonide HFA 160 Mcg Once Daily | -1.82 | Standard Error 0.10 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Placebo Once Daily | -1.28 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Ciclesonide HFA 80 Mcg Once Daily | -1.77 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Ciclesonide HFA 160 Mcg Once Daily | -1.60 | Standard Error 0.10 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment | Placebo Once Daily | -1.18 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Ciclesonide HFA 80 Mcg Once Daily | -1.94 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Ciclesonide HFA 160 Mcg Once Daily | -1.78 | Standard Error 0.10 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Placebo Once Daily | -1.25 | Standard Error 0.13 | units on a scale | |
| Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment. | Ciclesonide HFA 80 Mcg Once Daily | -2.01 | Standard Error 0.13 | units on a scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciclesonide HFA 80 Mcg Once Daily | 298 | |
| Overall Study | STARTED | Ciclesonide HFA 160 Mcg Once Daily | 505 | |
| Overall Study | STARTED | Placebo Once Daily | 307 | |
| Overall Study | COMPLETED | Ciclesonide HFA 80 Mcg Once Daily | 261 | |
| Overall Study | COMPLETED | Ciclesonide HFA 160 Mcg Once Daily | 439 | |
| Overall Study | COMPLETED | Placebo Once Daily | 265 | |
| Overall Study | NOT COMPLETED | Ciclesonide HFA 80 Mcg Once Daily | 37 | |
| Overall Study | NOT COMPLETED | Ciclesonide HFA 160 Mcg Once Daily | 66 | |
| Overall Study | NOT COMPLETED | Placebo Once Daily | 42 |
Source ClinicalTrials.gov
Adverse events138
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 | Abdominal pain | Gastrointestinal disorders | Ciclesonide HFA 80 Mcg Once Daily | 4 | 334 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Ciclesonide HFA 160 Mcg Once Daily | 7 | 475 | 8 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Once Daily | 7 | 243 | 7 |
| other | Nausea | Gastrointestinal disorders | Ciclesonide HFA 80 Mcg Once Daily | 9 | 334 | 10 |
| other | Nausea | Gastrointestinal disorders | Ciclesonide HFA 160 Mcg Once Daily | 8 | 475 | 8 |
| other | Nausea | Gastrointestinal disorders | Placebo Once Daily | 2 | 243 | 2 |
| other | Instillation site discomfort | General disorders | Ciclesonide HFA 80 Mcg Once Daily | 10 | 334 | 11 |
| other | Instillation site discomfort | General disorders | Ciclesonide HFA 160 Mcg Once Daily | 9 | 475 | 11 |
| other | Instillation site discomfort | General disorders | Placebo Once Daily | 0 | 243 | 0 |
| other | Bronchitis | Infections and infestations | Ciclesonide HFA 80 Mcg Once Daily | 7 | 334 | 7 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciclesonide HFA 80 Mcg Once Daily | ||
| Total, all-cause mortality | Ciclesonide HFA 160 Mcg Once Daily | ||
| Total, all-cause mortality | Placebo Once Daily | ||
| Total, other adverse events | Ciclesonide HFA 80 Mcg Once Daily | 148 | 334 |
| Total, other adverse events | Ciclesonide HFA 160 Mcg Once Daily | 234 | 475 |
| Total, other adverse events | Placebo Once Daily | 131 | 243 |
| Total, serious adverse events | Ciclesonide HFA 80 Mcg Once Daily | 6 | 298 |
| Total, serious adverse events | Ciclesonide HFA 160 Mcg Once Daily | 8 | 505 |
| Total, serious adverse events | Placebo Once Daily | 6 | 307 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22370530 | RESULT |
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 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.
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