Trial Outcomes & Findings for A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) (NCT NCT01654536)
NCT ID: NCT01654536
Last Updated: 2014-07-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
737 participants
Primary outcome timeframe
0-6 months
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
368
|
369
|
|
Overall Study
COMPLETED
|
324
|
331
|
|
Overall Study
NOT COMPLETED
|
44
|
38
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Physician Decision
|
12
|
8
|
|
Overall Study
Withdrawal by Subject
|
27
|
25
|
Baseline Characteristics
A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
Baseline characteristics by cohort
| Measure |
Ciclesonide Nasal Aerosol
n=368 Participants
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)
|
Ciclesonide Nasal Spray
n=369 Participants
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)
|
Total
n=737 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
322 Participants
n=99 Participants
|
321 Participants
n=107 Participants
|
643 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 14.09 • n=99 Participants
|
37.7 years
STANDARD_DEVIATION 14.03 • n=107 Participants
|
37.8 years
STANDARD_DEVIATION 14.05 • n=206 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=99 Participants
|
235 Participants
n=107 Participants
|
482 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
255 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
315 Participants
n=99 Participants
|
314 Participants
n=107 Participants
|
629 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
272 Participants
n=99 Participants
|
289 Participants
n=107 Participants
|
561 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
368 participants
n=99 Participants
|
369 participants
n=107 Participants
|
737 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
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
|
4 participants
|
|
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
|
0 participants
|
|
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
|
0 participants
|
|
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
|
4 participants
|
|
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
|
0 participants
|
PRIMARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
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
|
1.1 percentage of participants
|
|
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
|
0 percentage of participants
|
|
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
|
0 percentage of participants
|
|
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
|
1.1 percentage of participants
|
|
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
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Overall
|
53 participants
|
44 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
General Disorders and Administration Site Conditio
|
5 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Application site pain
|
5 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Infections and Infestations
|
11 participants
|
8 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Acute sinusitis
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinusitis
|
10 participants
|
7 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Injury, Poisoning and Procedural Complications
|
2 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Facial bones fracture
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Mucosal excoriation
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Scratch
|
2 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nervous System Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinus headache
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Respiratory, Thoracic and Mediastinal Disorders
|
41 participants
|
34 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Epistaxis
|
22 participants
|
26 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal congestion
|
4 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal discomfort
|
6 participants
|
4 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal dryness
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal mucosal discolouration
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal mucosal disorder
|
2 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal septum ulceration
|
1 participants
|
4 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Paranasal sinus hypersecretion
|
2 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Respiratory tract congestion
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Rhinalgia
|
2 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Rhinorrhoea
|
2 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinus congestion
|
3 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Sneezing
|
6 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Skin and Subcutaneous Tissue Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Scab
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Overall
|
14.4 percentage of participants
|
11.9 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
General Disorders and Administration Site Conditio
|
1.4 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Application site pain
|
1.4 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Infections and Infestations
|
3.0 percentage of participants
|
2.2 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Acute sinusitis
|
0.3 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinusitis
|
2.7 percentage of participants
|
1.9 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Injury, Poisoning and Procedural Complications
|
0.5 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Facial bones fracture
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Mucosal excoriation
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Scratch
|
0.5 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nervous System Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinus headache
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Respiratory, Thoracic and Mediastinal Disorders
|
11.2 percentage of participants
|
9.2 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Epistaxis
|
6.0 percentage of participants
|
7.0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal congestion
|
1.1 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal discomfort
|
1.6 percentage of participants
|
1.1 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal dryness
|
0.3 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal mucosal discolouration
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal mucosal disorder
|
0.5 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Nasal septum ulceration
|
0.3 percentage of participants
|
1.1 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Paranasal sinus hypersecretion
|
0.5 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Respiratory tract congestion
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Rhinalgia
|
0.5 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Rhinorrhoea
|
0.5 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Sinus congestion
|
0.8 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Sneezing
|
1.6 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Skin and Subcutaneous Tissue Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Scab
|
0 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Overall
|
121 participants
|
114 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
General Disorders and Administration Site Conditio
|
7 participants
|
3 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Application site pain
|
5 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Infections and Infestations
|
55 participants
|
46 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Bronchitis
|
5 participants
|
3 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Gastroenteritis viral
|
6 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Influenza
|
7 participants
|
3 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Nasopharyngitis
|
12 participants
|
11 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Sinusitis
|
10 participants
|
7 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Upper respiratory tract infection
|
12 participants
|
8 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Viral upper respiratory tract infection
|
5 participants
|
5 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Injury, Poisoning and Procedural Complications
|
11 participants
|
13 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Muscle strain
|
0 participants
|
4 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Nervous System Disorders
|
9 participants
|
14 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Headache
|
4 participants
|
9 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Respiratory, Thoracic and Mediastinal Disorders
|
49 participants
|
37 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Asthma
|
4 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Cough
|
4 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Epistaxis
|
22 participants
|
26 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Nasal congestion
|
4 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Nasal discomfort
|
6 participants
|
4 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Nasal septum ulceration
|
1 participants
|
4 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs.
Sneezing
|
6 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Overall
|
33.0 percentage of participants
|
30.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
General Disorders and Administration Site Conditio
|
1.9 percentage of participants
|
0.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Application site pain
|
1.4 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Infections and Infestations
|
15.0 percentage of participants
|
12.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Bronchitis
|
1.4 percentage of participants
|
0.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Gastroenteritis viral
|
1.6 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Influenza
|
1.9 percentage of participants
|
0.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Nasopharyngitis
|
3.3 percentage of participants
|
3.0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Sinusitis
|
2.7 percentage of participants
|
1.9 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Upper respiratory tract infection
|
3.3 percentage of participants
|
2.2 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Viral upper respiratory tract infection
|
1.4 percentage of participants
|
1.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Injury, Poisoning and Procedural Complications
|
3.0 percentage of participants
|
3.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Muscle strain
|
0 percentage of participants
|
1.1 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Nervous System Disorders
|
2.5 percentage of participants
|
3.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Headache
|
1.1 percentage of participants
|
2.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Respiratory, Thoracic and Mediastinal Disorders
|
13.4 percentage of participants
|
10.0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Asthma
|
1.1 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Cough
|
1.1 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Epistaxis
|
6.0 percentage of participants
|
7.0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Nasal congestion
|
1.1 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Nasal discomfort
|
1.6 percentage of participants
|
1.1 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Nasal septum ulceration
|
0.3 percentage of participants
|
1.1 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs.
Sneezing
|
1.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Migraine
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Respiratory, Thoracic and Mediastinal Disorders
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Overall
|
4 participants
|
5 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Cardiac Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Angina pectoris
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Coronary artery disease
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Hepatobiliary Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Bile duct stenosis
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Infections and Infestations
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Appendicitis
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Injury, Poisoning and Procedural Complications
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Facial bones fracture
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Limb injury
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Investigations
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Blood pressure increased
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Nervous System Disorders
|
2 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Lacunar infarction
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Reproductive System and Breast Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Postmenopausal haemorrhage
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Pulmonary embolism
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Appendicitis
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Overall
|
1.1 percentage of participants
|
1.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Cardiac Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Angina pectoris
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Coronary artery disease
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Hepatobiliary Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Bile duct stenosis
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Infections and Infestations
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Injury, Poisoning and Procedural Complications
|
0.3 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Facial bones fracture
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Limb injury
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Investigations
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Blood pressure increased
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Nervous System Disorders
|
0.5 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Lacunar infarction
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Migraine
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Reproductive System and Breast Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Postmenopausal haemorrhage
|
0 percentage of participants
|
0.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Respiratory, Thoracic and Mediastinal Disorders
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Pulmonary embolism
|
0.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Haematoma
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nasal congestion
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nasal discomfort
|
2 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Pulmonary embolism
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Sneezing
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Skin and Subcutaneous Tissue Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Urticaria
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Vascular Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Mucosal excoriation
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Overall
|
13 participants
|
12 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Cardiac Disorders
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Angina pectoris
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Coronary artery disease
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Ear and Labyrinth Disorders
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Ear pain
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Tinnitus
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Eye Disorders
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Vision blurred
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Infections and Infestations
|
3 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Bronchitis
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Pelvic inflammatory disease
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Upper respiratory tract infection
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Injury, Poisoning and Procedural Complications
|
0 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Facial bones fracture
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Investigations
|
1 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Blood pressure increased
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Intraocular pressure increased
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nervous System Disorders
|
3 participants
|
2 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Dizziness
|
0 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Headache
|
2 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Lacunar infarction
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nerve compression
|
1 participants
|
0 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Respiratory, Thoracic and Mediastinal Disorders
|
7 participants
|
5 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Asthma
|
2 participants
|
1 participants
|
|
The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Epistaxis
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Vision blurred
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Injury, Poisoning and Procedural Complications
|
0 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Facial bones fracture
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Mucosal excoriation
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Investigations
|
0.3 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Blood pressure increased
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Intraocular pressure increased
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nervous System Disorders
|
0.8 percentage of participants
|
0.5 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Dizziness
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Headache
|
0.5 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Lacunar infarction
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nerve compression
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Respiratory, Thoracic and Mediastinal Disorders
|
1.9 percentage of participants
|
1.4 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Asthma
|
0.5 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Epistaxis
|
0.3 percentage of participants
|
0.8 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nasal congestion
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Nasal discomfort
|
0.5 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Pulmonary embolism
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Sneezing
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Skin and Subcutaneous Tissue Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Urticaria
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Vascular Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Haematoma
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Overall
|
3.5 percentage of participants
|
3.2 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Cardiac Disorders
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Angina pectoris
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Coronary artery disease
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Ear and Labyrinth Disorders
|
0.3 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Ear pain
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Tinnitus
|
0 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Eye Disorders
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Infections and Infestations
|
0.8 percentage of participants
|
0.3 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Bronchitis
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Pelvic inflammatory disease
|
0.3 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Upper respiratory tract infection
|
0.3 percentage of participants
|
0.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsOutcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
Number of Subjects With Development of or Worsening in Lens Opacities.
|
51 participants
|
53 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsOutcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
Percentage of Subjects With Development of or Worsening in Lens Opacities.
|
13.9 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
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
|
6 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
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
|
1.6 percentage of partcipants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 0-6 monthsPopulation: 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.
Outcome measures
| Measure |
Ciclesonide Nasal Aerosol
n=367 Participants
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)
|
Ciclesonide Nasal Spray
n=370 Participants
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)
|
|---|---|---|
|
Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
|
0.3 percentage of participants
|
0.5 percentage of participants
|
Adverse Events
Ciclesonide Nasal Aerosol
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Ciclesonide Nasal Spray
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciclesonide Nasal Aerosol
n=367 participants at risk
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)
|
Ciclesonide Nasal Spray
n=370 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.27%
1/367 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.00%
0/370 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Investigations
Blood pressure
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Nervous system disorders
Lacunar infarction
|
0.27%
1/367 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.00%
0/370 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Nervous system disorders
Migraine
|
0.27%
1/367 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.00%
0/370 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage*
|
0.00%
0/367 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.27%
1/370 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/367 • Number of events 1 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
0.00%
0/370 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
Other adverse events
| Measure |
Ciclesonide Nasal Aerosol
n=367 participants at risk
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)
|
Ciclesonide Nasal Spray
n=370 participants at risk
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)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.0%
22/367 • Number of events 28 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
7.0%
26/370 • Number of events 28 • 0-6 months
Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.
|
Additional Information
Respiratory Medical Director
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER