Trial · NCT01067105
A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
NCT01067105, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2012-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older. Trials, record NCT01067105. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01067105
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
- NCT number
- NCT01067105
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 824 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- ciclesonide HFA 160 μg
- First posted
- 2010-02-11
- Last updated
- 2012-06-13
- Results first posted
- 2012-06-11
- Limitations and caveats
- Open label study investigating a dose higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 mcg is equivalent to 160 mcg.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Experiencing Adverse Events (AEs) | Weeks 1-26 | |
| Primary | Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | Weeks 1-26 | |
| Primary | Percentage of Subjects Who Discontinue Due to AEs. | Weeks 1-26 | |
| Secondary | Percentage of Subjects Experiencing Local Nasal AEs | Weeks 1-26 | Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. |
| Secondary | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | 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 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, and 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement. |
| Secondary | Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances | Weeks 0-12 | Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) \* 100% and therefore reported as a percentage. |
| Secondary | Number of Devices With Actuation Consistency | Weeks 0-6 and 6-12 | Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration |
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 | Percentage of Subjects Experiencing Adverse Events (AEs) | Weeks 1-26 | Intent to Treat Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | Weeks 1-26 | Intent to Treat Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects Who Discontinue Due to AEs. | Weeks 1-26 | Intent to Treat Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects Experiencing Local Nasal AEs | Weeks 1-26 | Intent to Treat Population | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | Intent to Treat Population. Subjects with missing date were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. | Baseline and Weeks 1-26 | Intent to Treat Population. Subjects with missing date were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, and 6 | Intent to Treat Population. Subjects with missing date were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. | Baseline and Months 1, 2, 3, 4, 5, 6 | Intent to Treat Population. Subjects with missing date were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances | Weeks 0-12 | Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses. | percentage of correct advances | MEAN |
| SECONDARY | Number of Devices With Actuation Consistency | Weeks 0-6 and 6-12 | Intent to Treat Population. | devices | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Experiencing Adverse Events (AEs) | Ciclesonide | 51.5 | percentage of participants | ||
| Percentage of Subjects Experiencing Serious Adverse Events (SAEs) | Ciclesonide | 1.8 | percentage of participants | ||
| Percentage of Subjects Who Discontinue Due to AEs. | Ciclesonide | 1.7 | percentage of participants | ||
| Percentage of Subjects Experiencing Local Nasal AEs | Ciclesonide | 29.4 | percentage of participants | ||
| Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. | Ciclesonide | -0.50 | Standard Deviation 1.46 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. | Ciclesonide | -0.54 | Standard Deviation 1.37 | units on a scale | |
| Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Ciclesonide | Month 1 (n=823) | -0.18 | Standard Deviation 1.26 | units on a scale |
| Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Ciclesonide | Month 2 (n=806) | -0.48 | Standard Deviation 1.49 | units on a scale |
| Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Ciclesonide | Month 3 (n=768) | -0.64 | Standard Deviation 1.57 | units on a scale |
| Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. | Ciclesonide | Month 4 (n=743) | -0.69 | Standard Deviation 1.70 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciclesonide | 824 | |
| Overall Study | COMPLETED | Ciclesonide | 683 | |
| Overall Study | NOT COMPLETED | Ciclesonide | 141 |
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 | Bronchitis | Infections and infestations | Ciclesonide | 21 | 824 | 24 |
| other | Nasopharyngitis | Infections and infestations | Ciclesonide | 31 | 824 | 35 |
| other | Sinusitis | Infections and infestations | Ciclesonide | 38 | 824 | 42 |
| other | Upper respiratory tract infection | Infections and infestations | Ciclesonide | 61 | 824 | 72 |
| other | Urinary tract infection | Immune system disorders | Ciclesonide | 22 | 824 | 23 |
| other | Viral upper respiratory tract infection | Infections and infestations | Ciclesonide | 17 | 824 | 20 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Ciclesonide | 21 | 824 | 23 |
| other | Headache | Nervous system disorders | Ciclesonide | 39 | 824 | 56 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Ciclesonide | 46 | 824 | 64 |
| other | Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | Ciclesonide | 13 | 824 | 14 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciclesonide | ||
| Total, other adverse events | Ciclesonide | 329 | 824 |
| Total, serious adverse events | Ciclesonide | 15 | 824 |
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/NCT01067105
GET https://conductscience.org/api/trials/v1/NCT01067105/results?page=2