Trial · NCT01654536
A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
NCT01654536, Phase 4, Completed, Sumitomo Pharma America, Inc.; results first posted 2014-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR). Trials, record NCT01654536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01654536
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
- NCT number
- NCT01654536
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 737 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- ciclesonide nasal aerosol, ciclesonide nasal spray
- First posted
- 2012-07-31
- Last updated
- 2014-07-24
- Results first posted
- 2014-07-24
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | 0-6 months | |
| Primary | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | 0-6 months | |
| Secondary | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months | |
| Secondary | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months | |
| Secondary | The Number of Subjects Experiencing Treatment Emergent AEs. | 0-6 months | |
| Secondary | The Percentage of Subjects Experiencing Treatment Emergent AEs. | 0-6 months | |
| Secondary | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months | |
| Secondary | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months | |
| Secondary | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months | |
| Secondary | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | participants | NUMBER |
| SECONDARY | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | participants | NUMBER |
| SECONDARY | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | percentage of participants | NUMBER |
| SECONDARY | The Number of Subjects Experiencing Treatment Emergent AEs. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | participants | NUMBER |
| SECONDARY | The Percentage of Subjects Experiencing Treatment Emergent AEs. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | percentage of participants | NUMBER |
| SECONDARY | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | participants | NUMBER |
| PRIMARY | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | percentage of participants | NUMBER |
| SECONDARY | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | percentage of participants | NUMBER |
| SECONDARY | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | participants | NUMBER |
| SECONDARY | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months | Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group456
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Aerosol | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 3 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Spray | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 4 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Aerosol | Nasal Mucosal Disorder | 2 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Spray | Nasal Mucosal Disorder | 0 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Aerosol | Nasal Septum Disorder | 0 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Spray | Nasal Septum Disorder | 0 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Aerosol | Nasal Septum Ulceration | 1 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Spray | Nasal Septum Ulceration | 4 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Aerosol | Nasal Septum Perforation | 0 | participants | |
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Ciclesonide Nasal Spray | Nasal Septum Perforation | 0 | participants |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 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 Nasal Aerosol | 368 | |
| Overall Study | STARTED | Ciclesonide Nasal Spray | 369 | |
| Overall Study | COMPLETED | Ciclesonide Nasal Aerosol | 324 | |
| Overall Study | COMPLETED | Ciclesonide Nasal Spray | 331 | |
| Overall Study | NOT COMPLETED | Ciclesonide Nasal Aerosol | 44 | |
| Overall Study | NOT COMPLETED | Ciclesonide Nasal Spray | 38 |
Source ClinicalTrials.gov
Adverse events24
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 | EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Ciclesonide Nasal Aerosol | 22 | 367 | 28 |
| other | EPISTAXIS | Respiratory, thoracic and mediastinal disorders | Ciclesonide Nasal Spray | 26 | 370 | 28 |
| serious | Angina pectoris | Cardiac disorders | Ciclesonide Nasal Aerosol | 0 | 367 | 0 |
| serious | Angina pectoris | Cardiac disorders | Ciclesonide Nasal Spray | 1 | 370 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Ciclesonide Nasal Aerosol | 0 | 367 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Ciclesonide Nasal Spray | 1 | 370 | 1 |
| serious | Bile duct stenosis | Hepatobiliary disorders | Ciclesonide Nasal Aerosol | 0 | 367 | 0 |
| serious | Bile duct stenosis | Hepatobiliary disorders | Ciclesonide Nasal Spray | 1 | 370 | 1 |
| serious | Appendicitis | Infections and infestations | Ciclesonide Nasal Aerosol | 0 | 367 | 0 |
| serious | Appendicitis | Infections and infestations | Ciclesonide Nasal Spray | 1 | 370 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciclesonide Nasal Aerosol | ||
| Total, all-cause mortality | Ciclesonide Nasal Spray | ||
| Total, other adverse events | Ciclesonide Nasal Aerosol | 22 | 367 |
| Total, other adverse events | Ciclesonide Nasal Spray | 26 | 370 |
| Total, serious adverse events | Ciclesonide Nasal Aerosol | 4 | 367 |
| Total, serious adverse events | Ciclesonide Nasal Spray | 5 | 370 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ciclesonide Nasal Aerosol vs Ciclesonide Nasal Spray: Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | Trial comparisons |
| Ciclesonide Nasal Aerosol vs Ciclesonide Nasal Spray: Number of Subjects With Development of or Worsening in Lens Opacities. | Trial comparisons |
| Ciclesonide Nasal Aerosol vs Ciclesonide Nasal Spray: Number of Subjects With Change From Baseline in Best Corrected Visual Acuity. | Trial comparisons |
| Ciclesonide Nasal Aerosol vs Ciclesonide Nasal Spray: 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/NCT01654536
GET https://conductscience.org/api/trials/v1/NCT01654536/results?page=2