Perennial Allergic Rhinitis
Conditions
Keywords
PAR
Brief summary
This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.
Detailed description
This is a 6 month, multicenter, randomized, open label, parallel group, safety study of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR. The objectives of this study are to evaluate the nasal and ocular safety of once daily dosing with ciclesonide nasal aerosol (Zetonna) 74 mcg and ciclesonide aqueous nasal spray (Omnaris) 200 mcg in subjects 12 years and older with PAR.
Interventions
ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)
ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or Subject's parent/guardian gives written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * Male or female 12 years and older, as of the Screening visit. * Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history. * A history of PAR to a relevant perennial allergen (eg, house dust mites, cockroach, molds, animal dander) for a minimum of one year immediately preceding the study Screening visit. The PAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past 12 months, and require treatment throughout the entire study period. * Subject, if female ≤ 65 years of age, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: * An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation. * Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. * Abstinence. * Subject must possess an educational level and degree of understanding of English that enables them to communicate suitably with the PI and study coordinator.
Exclusion criteria
* Female subject who is pregnant or lactating. * Current physical findings of nasal polyps, septal perforation, or nasal ulceration. (Subjects showing significant progression of nasal pathology between screening and randomization would be excluded at the discretion of the investigator.\] * Planned insertion of nasal septal jewelry during the study period. * Surgery (including biopsy) and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 30 days prior to the Screening visit. * Participation in any investigational drug trial within the 30 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial. * A known hypersensitivity to any corticosteroid or any of the excipients in the formulation of ciclesonide. * History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening visit. * History of alcohol or drug abuse within 2 years preceding the Screening visit. * History of a positive test for HIV, hepatitis B or hepatitis C. * Active asthma requiring treatment with inhaled or systemic corticosteroids. * Use of chronic treatment with agents known to promote the development of cataracts (potassium-sparing diuretics and allopurinol). * Non vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit. * Initiation of pimecrolimus cream 1% or greater or tacrolimus ointment 0.03% or greater during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to screening and use of a stable (maintenance) dose during the study period may be considered for inclusion. * Use of nasal corticosteroids within 14 days, or ocular, oral or parenteral within 6 months prior to randomization. * Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial: 1. impaired hepatic function including alcohol related liver disease or cirrhosis 2. diabetes mellitus 3. malignancy (excluding basal cell carcinoma) * Any condition that, in the judgment of the investigator, would preclude the subject from completing the protocol with capture of the assessments as written Ocular
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | 0-6 months |
| 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
| Measure | Time frame |
|---|---|
| The Number of Subjects Experiencing Treatment Emergent AEs. | 0-6 months |
| The Percentage of Subjects Experiencing Treatment Emergent AEs. | 0-6 months |
| The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months |
| The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | 0-6 months |
| The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months |
| The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | 0-6 months |
| The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months |
| Percentage of Subjects With Development of or Worsening in Lens Opacities. | 0-6 months |
| Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | 0-6 months |
| Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | 0-6 months |
| Number of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 0-6 months |
| Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 0-6 months |
| Number of Subjects With Development of or Worsening in Lens Opacities. | 0-6 months |
| The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | 0-6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciclesonide Nasal Aerosol Zetonna (ciclesonide) nasal aerosol 74 mcg
ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol) | 368 |
| Ciclesonide Nasal Spray Omnaris (ciclesonide) nasal spray 200 mcg
ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray) | 369 |
| Total | 737 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Physician Decision | 12 | 8 |
| Overall Study | Withdrawal by Subject | 27 | 25 |
Baseline characteristics
| Characteristic | Ciclesonide Nasal Aerosol | Ciclesonide Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 43 Participants | 83 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 322 Participants | 321 Participants | 643 Participants |
| Age, Continuous | 37.9 years STANDARD_DEVIATION 14.09 | 37.7 years STANDARD_DEVIATION 14.03 | 37.8 years STANDARD_DEVIATION 14.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 53 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 315 Participants | 314 Participants | 629 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 58 Participants | 127 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 272 Participants | 289 Participants | 561 Participants |
| Region of Enrollment United States | 368 participants | 369 participants | 737 participants |
| Sex: Female, Male Female | 247 Participants | 235 Participants | 482 Participants |
| Sex: Female, Male Male | 121 Participants | 134 Participants | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 367 | 26 / 370 |
| serious Total, serious adverse events | 4 / 367 | 5 / 370 |
Outcome results
Primary
The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Disorder | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Perforation | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Ulceration | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Mucosal Disorder | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 3 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Mucosal Disorder | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Disorder | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Ulceration | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Perforation | 0 participants |
Primary
The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Mucosal Disorder | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Ulceration | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Disorder | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Perforation | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 0.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Perforation | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Any Nasal Mucosal Disorder, Septum Disorder, or Na | 1.1 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Mucosal Disorder | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Disorder | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE) | Nasal Septum Ulceration | 1.1 percentage of participants |
Secondary
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Number of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 1 participants |
| Ciclesonide Nasal Spray | Number of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 2 participants |
Secondary
Number of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Number of Subjects With Development of or Worsening in Lens Opacities. | 51 participants |
| Ciclesonide Nasal Spray | Number of Subjects With Development of or Worsening in Lens Opacities. | 53 participants |
Secondary
Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | 9 participants |
| 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 | 6 participants |
Secondary
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity. | 0.5 percentage of participants |
Secondary
Percentage of Subjects With Development of or Worsening in Lens Opacities.
Time frame: 0-6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Percentage of Subjects With Development of or Worsening in Lens Opacities. | 13.9 percentage of participants |
| Ciclesonide Nasal Spray | Percentage of Subjects With Development of or Worsening in Lens Opacities. | 14.3 percentage of participants |
Secondary
Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Nasal Aerosol | Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | 2.5 percentage of partcipants |
| Ciclesonide Nasal Spray | Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye | 1.6 percentage of partcipants |
Secondary
The Number of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Overall | 121 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Infections and Infestations | 55 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Bronchitis | 5 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Gastroenteritis viral | 6 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Influenza | 7 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasopharyngitis | 12 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Upper respiratory tract infection | 12 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Viral upper respiratory tract infection | 5 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Injury, Poisoning and Procedural Complications | 11 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Muscle strain | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Nervous System Disorders | 9 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Headache | 4 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Cough | 4 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Epistaxis | 22 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal congestion | 4 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal discomfort | 6 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal septum ulceration | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Sneezing | 6 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | General Disorders and Administration Site Conditio | 7 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Application site pain | 5 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Sinusitis | 10 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Respiratory, Thoracic and Mediastinal Disorders | 49 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs. | Asthma | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Nervous System Disorders | 14 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Overall | 114 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Application site pain | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal discomfort | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Infections and Infestations | 46 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Headache | 9 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Bronchitis | 3 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Asthma | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Gastroenteritis viral | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Respiratory, Thoracic and Mediastinal Disorders | 37 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Influenza | 3 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Cough | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasopharyngitis | 11 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Sinusitis | 7 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal septum ulceration | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Upper respiratory tract infection | 8 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Epistaxis | 26 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Viral upper respiratory tract infection | 5 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | General Disorders and Administration Site Conditio | 3 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Injury, Poisoning and Procedural Complications | 13 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Nasal congestion | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Muscle strain | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs. | Sneezing | 0 participants |
Secondary
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Infections and Infestations | 3 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Intraocular pressure increased | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear pain | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nervous System Disorders | 3 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Bronchitis | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Dizziness | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Coronary artery disease | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Headache | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pelvic inflammatory disease | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Lacunar infarction | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Tinnitus | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nerve compression | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Upper respiratory tract infection | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Respiratory, Thoracic and Mediastinal Disorders | 7 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Angina pectoris | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Asthma | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Injury, Poisoning and Procedural Complications | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Epistaxis | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Eye Disorders | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal congestion | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Facial bones fracture | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal discomfort | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear and Labyrinth Disorders | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pulmonary embolism | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Mucosal excoriation | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Sneezing | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vision blurred | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Skin and Subcutaneous Tissue Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Investigations | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Urticaria | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Cardiac Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vascular Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Blood pressure increased | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Haematoma | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Overall | 13 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Haematoma | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Overall | 12 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Cardiac Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Angina pectoris | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Coronary artery disease | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear and Labyrinth Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear pain | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Tinnitus | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Eye Disorders | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vision blurred | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Infections and Infestations | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Bronchitis | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pelvic inflammatory disease | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Upper respiratory tract infection | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Injury, Poisoning and Procedural Complications | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Facial bones fracture | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Mucosal excoriation | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Investigations | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Blood pressure increased | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Intraocular pressure increased | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nervous System Disorders | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Dizziness | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Headache | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Lacunar infarction | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nerve compression | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Respiratory, Thoracic and Mediastinal Disorders | 5 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Asthma | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Epistaxis | 3 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal congestion | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal discomfort | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pulmonary embolism | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Sneezing | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Skin and Subcutaneous Tissue Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Urticaria | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vascular Disorders | 1 participants |
Secondary
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus congestion | 3 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Facial bones fracture | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Mucosal excoriation | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Scratch | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nervous System Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus headache | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory, Thoracic and Mediastinal Disorders | 41 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Epistaxis | 22 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal congestion | 4 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal discomfort | 6 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal dryness | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal discolouration | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal disorder | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal septum ulceration | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Paranasal sinus hypersecretion | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory tract congestion | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinalgia | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sneezing | 6 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Skin and Subcutaneous Tissue Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Scab | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Overall | 53 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | General Disorders and Administration Site Conditio | 5 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Application site pain | 5 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Infections and Infestations | 11 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Acute sinusitis | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinusitis | 10 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Injury, Poisoning and Procedural Complications | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinorrhoea | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Paranasal sinus hypersecretion | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinusitis | 7 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Facial bones fracture | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory tract congestion | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Mucosal excoriation | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Application site pain | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Scratch | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus congestion | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nervous System Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinorrhoea | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus headache | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Sneezing | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory, Thoracic and Mediastinal Disorders | 34 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Infections and Infestations | 8 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Epistaxis | 26 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Skin and Subcutaneous Tissue Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal congestion | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Injury, Poisoning and Procedural Complications | 2 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal discomfort | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Scab | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal dryness | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Acute sinusitis | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal discolouration | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Overall | 44 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal disorder | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinalgia | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal septum ulceration | 4 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Nasal AEs. | General Disorders and Administration Site Conditio | 0 participants |
Secondary
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Overall | 4 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Cardiac Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Angina pectoris | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Coronary artery disease | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Hepatobiliary Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Bile duct stenosis | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Infections and Infestations | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Appendicitis | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Injury, Poisoning and Procedural Complications | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Facial bones fracture | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Limb injury | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Investigations | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Blood pressure increased | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Nervous System Disorders | 2 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Lacunar infarction | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Migraine | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Reproductive System and Breast Disorders | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Postmenopausal haemorrhage | 0 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Respiratory, Thoracic and Mediastinal Disorders | 1 participants |
| Ciclesonide Nasal Aerosol | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Pulmonary embolism | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Postmenopausal haemorrhage | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Overall | 5 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Limb injury | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Cardiac Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Migraine | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Angina pectoris | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Investigations | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Coronary artery disease | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Pulmonary embolism | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Hepatobiliary Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Blood pressure increased | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Bile duct stenosis | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Reproductive System and Breast Disorders | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Infections and Infestations | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Nervous System Disorders | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Appendicitis | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Respiratory, Thoracic and Mediastinal Disorders | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Injury, Poisoning and Procedural Complications | 1 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Lacunar infarction | 0 participants |
| Ciclesonide Nasal Spray | The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Facial bones fracture | 1 participants |
Secondary
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Overall | 33.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | General Disorders and Administration Site Conditio | 1.9 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Application site pain | 1.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Infections and Infestations | 15.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Bronchitis | 1.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Gastroenteritis viral | 1.6 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Influenza | 1.9 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasopharyngitis | 3.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Sinusitis | 2.7 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Upper respiratory tract infection | 3.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Viral upper respiratory tract infection | 1.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Injury, Poisoning and Procedural Complications | 3.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Muscle strain | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nervous System Disorders | 2.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Headache | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Respiratory, Thoracic and Mediastinal Disorders | 13.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Asthma | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Cough | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Epistaxis | 6.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal congestion | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal discomfort | 1.6 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal septum ulceration | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Sneezing | 1.6 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Injury, Poisoning and Procedural Complications | 3.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Overall | 30.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Cough | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | General Disorders and Administration Site Conditio | 0.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Muscle strain | 1.1 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Application site pain | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal discomfort | 1.1 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Infections and Infestations | 12.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nervous System Disorders | 3.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Bronchitis | 0.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Epistaxis | 7.0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Gastroenteritis viral | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Headache | 2.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Influenza | 0.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Sneezing | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasopharyngitis | 3.0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Respiratory, Thoracic and Mediastinal Disorders | 10.0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Sinusitis | 1.9 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal congestion | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Upper respiratory tract infection | 2.2 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Asthma | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Viral upper respiratory tract infection | 1.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs. | Nasal septum ulceration | 1.1 percentage of participants |
Secondary
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Infections and Infestations | 0.8 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Intraocular pressure increased | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear pain | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nervous System Disorders | 0.8 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Bronchitis | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Dizziness | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Coronary artery disease | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Headache | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pelvic inflammatory disease | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Lacunar infarction | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Tinnitus | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nerve compression | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Upper respiratory tract infection | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Respiratory, Thoracic and Mediastinal Disorders | 1.9 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Angina pectoris | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Asthma | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Injury, Poisoning and Procedural Complications | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Epistaxis | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Eye Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal congestion | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Facial bones fracture | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal discomfort | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear and Labyrinth Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pulmonary embolism | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Mucosal excoriation | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Sneezing | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Overall | 3.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Skin and Subcutaneous Tissue Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vision blurred | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Investigations | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vascular Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Cardiac Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Haematoma | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Blood pressure increased | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Urticaria | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Sneezing | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Overall | 3.2 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Cardiac Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Angina pectoris | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Coronary artery disease | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear and Labyrinth Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Ear pain | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Tinnitus | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Eye Disorders | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vision blurred | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Infections and Infestations | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Bronchitis | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pelvic inflammatory disease | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Upper respiratory tract infection | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Injury, Poisoning and Procedural Complications | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Facial bones fracture | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Mucosal excoriation | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Investigations | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Blood pressure increased | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Intraocular pressure increased | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nervous System Disorders | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Dizziness | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Headache | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Lacunar infarction | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nerve compression | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Respiratory, Thoracic and Mediastinal Disorders | 1.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Asthma | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Epistaxis | 0.8 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal congestion | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Nasal discomfort | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Pulmonary embolism | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Skin and Subcutaneous Tissue Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Urticaria | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Vascular Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation. | Haematoma | 0.3 percentage of participants |
Secondary
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal congestion | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Acute sinusitis | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal discomfort | 1.6 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Mucosal excoriation | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal dryness | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | General Disorders and Administration Site Conditio | 1.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal discolouration | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Scratch | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal disorder | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinusitis | 2.7 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal septum ulceration | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nervous System Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Paranasal sinus hypersecretion | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Infections and Infestations | 3.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory tract congestion | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus headache | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinalgia | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Injury, Poisoning and Procedural Complications | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinorrhoea | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory, Thoracic and Mediastinal Disorders | 11.2 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus congestion | 0.8 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Application site pain | 1.4 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sneezing | 1.6 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Epistaxis | 6.0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Skin and Subcutaneous Tissue Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Facial bones fracture | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Scab | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Overall | 14.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Scab | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Overall | 11.9 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | General Disorders and Administration Site Conditio | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Application site pain | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Infections and Infestations | 2.2 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Acute sinusitis | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinusitis | 1.9 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Injury, Poisoning and Procedural Complications | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Facial bones fracture | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Mucosal excoriation | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Scratch | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nervous System Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus headache | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory, Thoracic and Mediastinal Disorders | 9.2 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Epistaxis | 7.0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal congestion | 0.5 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal discomfort | 1.1 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal dryness | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal discolouration | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal mucosal disorder | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Nasal septum ulceration | 1.1 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Paranasal sinus hypersecretion | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Respiratory tract congestion | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinalgia | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Rhinorrhoea | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sinus congestion | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Sneezing | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs. | Skin and Subcutaneous Tissue Disorders | 0.3 percentage of participants |
Secondary
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Time frame: 0-6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Overall | 1.1 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Cardiac Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Angina pectoris | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Coronary artery disease | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Hepatobiliary Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Bile duct stenosis | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Infections and Infestations | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Injury, Poisoning and Procedural Complications | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Facial bones fracture | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Limb injury | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Investigations | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Blood pressure increased | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Nervous System Disorders | 0.5 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Lacunar infarction | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Migraine | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Reproductive System and Breast Disorders | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Postmenopausal haemorrhage | 0 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Respiratory, Thoracic and Mediastinal Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Pulmonary embolism | 0.3 percentage of participants |
| Ciclesonide Nasal Aerosol | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Appendicitis | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Limb injury | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Overall | 1.4 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Migraine | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Cardiac Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Investigations | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Angina pectoris | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Pulmonary embolism | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Coronary artery disease | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Blood pressure increased | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Hepatobiliary Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Reproductive System and Breast Disorders | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Bile duct stenosis | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Nervous System Disorders | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Infections and Infestations | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Appendicitis | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Respiratory, Thoracic and Mediastinal Disorders | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Injury, Poisoning and Procedural Complications | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Lacunar infarction | 0 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Facial bones fracture | 0.3 percentage of participants |
| Ciclesonide Nasal Spray | The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs). | Postmenopausal haemorrhage | 0.4 percentage of participants |