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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01654536
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Perennial Allergic Rhinitis
Interventions Drug: ciclesonide nasal aerosol
Drug: ciclesonide nasal spray
Enrollment 737
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description

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)

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)

Period Title: Overall Study
Started 368 369
Completed 324 331
Not Completed 44 38
Reason Not Completed
Lost to Follow-up             5             5
Physician Decision             12             8
Withdrawal by Subject             27             25
Arm/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray Total
Hide Arm/Group Description

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)

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 of all reporting groups
Overall Number of Baseline Participants 368 369 737
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 368 participants 369 participants 737 participants
<=18 years
40
  10.9%
43
  11.7%
83
  11.3%
Between 18 and 65 years
322
  87.5%
321
  87.0%
643
  87.2%
>=65 years
6
   1.6%
5
   1.4%
11
   1.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 368 participants 369 participants 737 participants
37.9  (14.09) 37.7  (14.03) 37.8  (14.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 368 participants 369 participants 737 participants
Female
247
  67.1%
235
  63.7%
482
  65.4%
Male
121
  32.9%
134
  36.3%
255
  34.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 368 participants 369 participants 737 participants
Hispanic or Latino
52
  14.1%
53
  14.4%
105
  14.2%
Not Hispanic or Latino
315
  85.6%
314
  85.1%
629
  85.3%
Unknown or Not Reported
1
   0.3%
2
   0.5%
3
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 368 participants 369 participants 737 participants
American Indian or Alaska Native
2
   0.5%
1
   0.3%
3
   0.4%
Asian
13
   3.5%
13
   3.5%
26
   3.5%
Native Hawaiian or Other Pacific Islander
1
   0.3%
2
   0.5%
3
   0.4%
Black or African American
69
  18.8%
58
  15.7%
127
  17.2%
White
272
  73.9%
289
  78.3%
561
  76.1%
More than one race
8
   2.2%
3
   0.8%
11
   1.5%
Unknown or Not Reported
3
   0.8%
3
   0.8%
6
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 368 participants 369 participants 737 participants
368 369 737
1.Primary Outcome
Title The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
Any Nasal Mucosal Disorder, Septum Disorder, or Na 3 4
Nasal Mucosal Disorder 2 0
Nasal Septum Disorder 0 0
Nasal Septum Ulceration 1 4
Nasal Septum Perforation 0 0
2.Primary Outcome
Title The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
Any Nasal Mucosal Disorder, Septum Disorder, or Na 0.8 1.1
Nasal Mucosal Disorder 0.5 0
Nasal Septum Disorder 0 0
Nasal Septum Ulceration 0.3 1.1
Nasal Septum Perforation 0 0
3.Secondary Outcome
Title The Number of Subjects Experiencing Treatment Emergent Nasal AEs.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
Overall 53 44
General Disorders and Administration Site Conditio 5 0
Application site pain 5 0
Infections and Infestations 11 8
Acute sinusitis 1 1
Sinusitis 10 7
Injury, Poisoning and Procedural Complications 2 2
Facial bones fracture 0 1
Mucosal excoriation 0 1
Scratch 2 0
Nervous System Disorders 0 1
Sinus headache 0 1
Respiratory, Thoracic and Mediastinal Disorders 41 34
Epistaxis 22 26
Nasal congestion 4 2
Nasal discomfort 6 4
Nasal dryness 1 1
Nasal mucosal discolouration 0 1
Nasal mucosal disorder 2 0
Nasal septum ulceration 1 4
Paranasal sinus hypersecretion 2 1
Respiratory tract congestion 1 0
Rhinalgia 2 0
Rhinorrhoea 2 0
Sinus congestion 3 1
Sneezing 6 0
Skin and Subcutaneous Tissue Disorders 0 1
Scab 0 1
4.Secondary Outcome
Title The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
Overall 14.4 11.9
General Disorders and Administration Site Conditio 1.4 0
Application site pain 1.4 0
Infections and Infestations 3.0 2.2
Acute sinusitis 0.3 0.3
Sinusitis 2.7 1.9
Injury, Poisoning and Procedural Complications 0.5 0.5
Facial bones fracture 0 0.3
Mucosal excoriation 0 0.3
Scratch 0.5 0
Nervous System Disorders 0 0.3
Sinus headache 0 0.3
Respiratory, Thoracic and Mediastinal Disorders 11.2 9.2
Epistaxis 6.0 7.0
Nasal congestion 1.1 0.5
Nasal discomfort 1.6 1.1
Nasal dryness 0.3 0.3
Nasal mucosal discolouration 0 0.3
Nasal mucosal disorder 0.5 0
Nasal septum ulceration 0.3 1.1
Paranasal sinus hypersecretion 0.5 0.3
Respiratory tract congestion 0.3 0
Rhinalgia 0.5 0
Rhinorrhoea 0.5 0
Sinus congestion 0.8 0.3
Sneezing 1.6 0
Skin and Subcutaneous Tissue Disorders 0 0.3
Scab 0 0.3
5.Secondary Outcome
Title The Number of Subjects Experiencing Treatment Emergent AEs.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
Overall 121 114
General Disorders and Administration Site Conditio 7 3
Application site pain 5 0
Infections and Infestations 55 46
Bronchitis 5 3
Gastroenteritis viral 6 0
Influenza 7 3
Nasopharyngitis 12 11
Sinusitis 10 7
Upper respiratory tract infection 12 8
Viral upper respiratory tract infection 5 5
Injury, Poisoning and Procedural Complications 11 13
Muscle strain 0 4
Nervous System Disorders 9 14
Headache 4 9
Respiratory, Thoracic and Mediastinal Disorders 49 37
Asthma 4 1
Cough 4 2
Epistaxis 22 26
Nasal congestion 4 2
Nasal discomfort 6 4
Nasal septum ulceration 1 4
Sneezing 6 0
6.Secondary Outcome
Title The Percentage of Subjects Experiencing Treatment Emergent AEs.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
Overall 33.0 30.8
General Disorders and Administration Site Conditio 1.9 0.8
Application site pain 1.4 0
Infections and Infestations 15.0 12.4
Bronchitis 1.4 0.8
Gastroenteritis viral 1.6 0
Influenza 1.9 0.8
Nasopharyngitis 3.3 3.0
Sinusitis 2.7 1.9
Upper respiratory tract infection 3.3 2.2
Viral upper respiratory tract infection 1.4 1.4
Injury, Poisoning and Procedural Complications 3.0 3.5
Muscle strain 0 1.1
Nervous System Disorders 2.5 3.8
Headache 1.1 2.4
Respiratory, Thoracic and Mediastinal Disorders 13.4 10.0
Asthma 1.1 0.3
Cough 1.1 0.5
Epistaxis 6.0 7.0
Nasal congestion 1.1 0.5
Nasal discomfort 1.6 1.1
Nasal septum ulceration 0.3 1.1
Sneezing 1.6 0
7.Secondary Outcome
Title The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

Zetona (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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
Overall 4 5
Cardiac Disorders 0 1
Angina pectoris 0 1
Coronary artery disease 0 1
Hepatobiliary Disorders 0 1
Bile duct stenosis 0 1
Infections and Infestations 0 1
Appendicitis 0 1
Injury, Poisoning and Procedural Complications 1 1
Facial bones fracture 0 1
Limb injury 1 0
Investigations 0 1
Blood pressure increased 0 1
Nervous System Disorders 2 0
Lacunar infarction 1 0
Migraine 1 0
Reproductive System and Breast Disorders 0 1
Postmenopausal haemorrhage 0 1
Respiratory, Thoracic and Mediastinal Disorders 1 0
Pulmonary embolism 1 0
8.Secondary Outcome
Title The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
Overall 1.1 1.4
Cardiac Disorders 0 0.3
Angina pectoris 0 0.3
Coronary artery disease 0 0.3
Hepatobiliary Disorders 0 0.3
Bile duct stenosis 0 0.3
Infections and Infestations 0 0.3
Appendicitis 0 0.3
Injury, Poisoning and Procedural Complications 0.3 0.3
Facial bones fracture 0 0.3
Limb injury 0.3 0
Investigations 0 0.3
Blood pressure increased 0 0.3
Nervous System Disorders 0.5 0
Lacunar infarction 0.3 0
Migraine 0.3 0
Reproductive System and Breast Disorders 0 0.3
Postmenopausal haemorrhage 0 0.4
Respiratory, Thoracic and Mediastinal Disorders 0.3 0
Pulmonary embolism 0.3 0
9.Secondary Outcome
Title The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
Overall 13 12
Cardiac Disorders 0 1
Angina pectoris 0 1
Coronary artery disease 0 1
Ear and Labyrinth Disorders 1 1
Ear pain 1 0
Tinnitus 0 1
Eye Disorders 1 0
Vision blurred 1 0
Infections and Infestations 3 1
Bronchitis 1 0
Pelvic inflammatory disease 1 0
Upper respiratory tract infection 1 1
Injury, Poisoning and Procedural Complications 0 2
Facial bones fracture 0 1
Mucosal excoriation 0 1
Investigations 1 1
Blood pressure increased 0 1
Intraocular pressure increased 1 0
Nervous System Disorders 3 2
Dizziness 0 1
Headache 2 1
Lacunar infarction 1 0
Nerve compression 1 0
Respiratory, Thoracic and Mediastinal Disorders 7 5
Asthma 2 1
Epistaxis 1 3
Nasal congestion 0 1
Nasal discomfort 2 1
Pulmonary embolism 1 0
Sneezing 1 0
Skin and Subcutaneous Tissue Disorders 0 1
Urticaria 0 1
Vascular Disorders 0 1
Haematoma 0 1
10.Secondary Outcome
Title The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
Overall 3.5 3.2
Cardiac Disorders 0 0.3
Angina pectoris 0 0.3
Coronary artery disease 0 0.3
Ear and Labyrinth Disorders 0.3 0.3
Ear pain 0.3 0
Tinnitus 0 0.3
Eye Disorders 0.3 0
Vision blurred 0.3 0
Infections and Infestations 0.8 0.3
Bronchitis 0.3 0
Pelvic inflammatory disease 0.3 0
Upper respiratory tract infection 0.3 0.3
Injury, Poisoning and Procedural Complications 0 0.5
Facial bones fracture 0 0.3
Mucosal excoriation 0 0.3
Investigations 0.3 0.3
Blood pressure increased 0 0.3
Intraocular pressure increased 0.3 0
Nervous System Disorders 0.8 0.5
Dizziness 0 0.3
Headache 0.5 0.3
Lacunar infarction 0.3 0
Nerve compression 0.3 0
Respiratory, Thoracic and Mediastinal Disorders 1.9 1.4
Asthma 0.5 0.3
Epistaxis 0.3 0.8
Nasal congestion 0 0.3
Nasal discomfort 0.5 0.3
Pulmonary embolism 0.3 0
Sneezing 0.3 0
Skin and Subcutaneous Tissue Disorders 0 0.3
Urticaria 0 0.3
Vascular Disorders 0 0.3
Haematoma 0 0.3
11.Secondary Outcome
Title Number of Subjects With Development of or Worsening in Lens Opacities.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
51 53
12.Secondary Outcome
Title Percentage of Subjects With Development of or Worsening in Lens Opacities.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
13.9 14.3
13.Secondary Outcome
Title Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
9 6
14.Secondary Outcome
Title Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of partcipants
2.5 1.6
15.Secondary Outcome
Title Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Hide Description [Not Specified]
Time Frame 0-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: participants
1 2
16.Secondary Outcome
Title Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.
Hide Description [Not Specified]
Time Frame 0-6 months
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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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
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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)

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 Number of Participants Analyzed 367 370
Measure Type: Number
Unit of Measure: percentage of participants
0.3 0.5
Time Frame 0-6 months
Adverse Event Reporting Description 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/Group Title Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
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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 200 mcg

ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)

All-Cause Mortality
Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
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Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/367 (1.09%)      5/370 (1.35%)    
Cardiac disorders     
Angina pectoris  0/367 (0.00%)  0 1/370 (0.27%)  1
Coronary artery disease  0/367 (0.00%)  0 1/370 (0.27%)  1
Hepatobiliary disorders     
Bile duct stenosis  0/367 (0.00%)  0 1/370 (0.27%)  1
Infections and infestations     
Appendicitis  0/367 (0.00%)  0 1/370 (0.27%)  1
Injury, poisoning and procedural complications     
Facial bones fracture  0/367 (0.00%)  0 1/370 (0.27%)  1
Limb injury  1/367 (0.27%)  1 0/370 (0.00%)  0
Investigations     
Blood pressure  0/367 (0.00%)  0 1/370 (0.27%)  1
Nervous system disorders     
Lacunar infarction  1/367 (0.27%)  1 0/370 (0.00%)  0
Migraine  1/367 (0.27%)  1 0/370 (0.00%)  0
Reproductive system and breast disorders     
Postmenopausal haemorrhage*  0/367 (0.00%)  0 1/370 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1/367 (0.27%)  1 0/370 (0.00%)  0
1
Term from vocabulary, MedDRA Version 13.1
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Frequency Threshold for Reporting Other Adverse Events 5%
Ciclesonide Nasal Aerosol Ciclesonide Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/367 (5.99%)      26/370 (7.03%)    
Respiratory, thoracic and mediastinal disorders     
EPISTAXIS  22/367 (5.99%)  28 26/370 (7.03%)  28
1
Term from vocabulary, MedDRA Version 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Respiratory Medical Director
Organization: Sunovion
Phone: 1-866-503-6351
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01654536    
Other Study ID Numbers: SEP060-401
First Submitted: July 27, 2012
First Posted: July 31, 2012
Results First Submitted: June 25, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014