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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01654536
First received: July 27, 2012
Last updated: July 23, 2014
Last verified: July 2014
Results First Received: June 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: ciclesonide nasal aerosol
Drug: ciclesonide nasal spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Ciclesonide Nasal Aerosol   Ciclesonide Nasal Spray
STARTED   368   369 
COMPLETED   324   331 
NOT COMPLETED   44   38 
Lost to Follow-up                5                5 
Physician Decision                12                8 
Withdrawal by Subject                27                25 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
   Ciclesonide Nasal Aerosol   Ciclesonide Nasal Spray   Total 
Overall Participants Analyzed 
[Units: Participants]
 368   369   737 
Age 
[Units: Participants]
     
<=18 years   40   43   83 
Between 18 and 65 years   322   321   643 
>=65 years   6   5   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.9  (14.09)   37.7  (14.03)   37.8  (14.05) 
Gender 
[Units: Participants]
     
Female   247   235   482 
Male   121   134   255 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   52   53   105 
Not Hispanic or Latino   315   314   629 
Unknown or Not Reported   1   2   3 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   2   1   3 
Asian   13   13   26 
Native Hawaiian or Other Pacific Islander   1   2   3 
Black or African American   69   58   127 
White   272   289   561 
More than one race   8   3   11 
Unknown or Not Reported   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   368   369   737 


  Outcome Measures
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1.  Primary:   The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)   [ Time Frame: 0-6 months ]

2.  Primary:   The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)   [ Time Frame: 0-6 months ]

3.  Secondary:   The Number of Subjects Experiencing Treatment Emergent Nasal AEs.   [ Time Frame: 0-6 months ]

4.  Secondary:   The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.   [ Time Frame: 0-6 months ]

5.  Secondary:   The Number of Subjects Experiencing Treatment Emergent AEs.   [ Time Frame: 0-6 months ]

6.  Secondary:   The Percentage of Subjects Experiencing Treatment Emergent AEs.   [ Time Frame: 0-6 months ]

7.  Secondary:   The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).   [ Time Frame: 0-6 months ]

8.  Secondary:   The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).   [ Time Frame: 0-6 months ]

9.  Secondary:   The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.   [ Time Frame: 0-6 months ]

10.  Secondary:   The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.   [ Time Frame: 0-6 months ]

11.  Secondary:   Number of Subjects With Development of or Worsening in Lens Opacities.   [ Time Frame: 0-6 months ]

12.  Secondary:   Percentage of Subjects With Development of or Worsening in Lens Opacities.   [ Time Frame: 0-6 months ]

13.  Secondary:   Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye   [ Time Frame: 0-6 months ]

14.  Secondary:   Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye   [ Time Frame: 0-6 months ]

15.  Secondary:   Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.   [ Time Frame: 0-6 months ]

16.  Secondary:   Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.   [ Time Frame: 0-6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Respiratory Medical Director
Organization: Sunovion
phone: 1-866-503-6351



Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01654536     History of Changes
Other Study ID Numbers: SEP060-401
Study First Received: July 27, 2012
Results First Received: June 25, 2014
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration