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A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01458275
First received: October 20, 2011
Last updated: April 16, 2014
Last verified: April 2014
Results First Received: March 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: Ciclesonide nasal aerosol 37 mcg
Drug: ciclesonide nasal aerosol 74 mcg
Drug: Placebo

  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
Placebo Placebo: Placebo - one actuation per nostril
Ciclesonide Nasal Aerosol 37mcg ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
Ciclesonide Nasal Aerosol 74 mcg ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg

Participant Flow:   Overall Study
    Placebo     Ciclesonide Nasal Aerosol 37mcg     Ciclesonide Nasal Aerosol 74 mcg  
STARTED     283     282     282  
COMPLETED     269     269     273  
NOT COMPLETED     14     13     9  
Adverse Event                 3                 4                 1  
Lost to Follow-up                 3                 2                 5  
Protocol Violation                 5                 5                 2  
Withdrawal by Subject                 3                 2                 1  



  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
Placebo Placebo: Placebo - one actuation per nostril
Ciclesonide Nasal Aerosol 37mcg ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
Ciclesonide Nasal Aerosol 74 mcg ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
Total Total of all reporting groups

Baseline Measures
    Placebo     Ciclesonide Nasal Aerosol 37mcg     Ciclesonide Nasal Aerosol 74 mcg     Total  
Number of Participants  
[units: participants]
  283     282     282     847  
Age  
[units: participants]
       
<=18 years     283     282     282     847  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  8.6  ± 1.72     8.5  ± 1.64     8.7  ± 1.65     8.6  ± 1.65  
Age, Customized  
[units: participants]
       
6-8 Years     131     123     120     374  
9-11 Years     152     159     162     473  
Gender  
[units: participants]
       
Female     131     123     120     374  
Male     152     159     162     473  
Region of Enrollment  
[units: participants]
       
United States     283     282     282     847  



  Outcome Measures
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1.  Primary:   Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period   [ Time Frame: Weeks 0 - 2 ]

2.  Secondary:   Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period   [ Time Frame: Weeks 0 - 2 ]

3.  Secondary:   Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.   [ Time Frame: Weeks 0 - 2 ]

4.  Secondary:   Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.   [ Time Frame: Weeks 0 - 2 ]

5.  Secondary:   Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period   [ Time Frame: Weeks 0 - 2 ]

6.  Secondary:   Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.   [ Time Frame: Weeks 0 - 2 ]

7.  Secondary:   Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period   [ Time Frame: Weeks 0 - 2 ]

8.  Secondary:   Number of Subjects Experiencing Treatment-emergent AEs   [ Time Frame: Weeks 0 - 3 ]

9.  Secondary:   Percentage of Subjects Experiencing Treatment-emergent AEs   [ Time Frame: Weeks 0 - 3 ]

10.  Secondary:   Treatment-emergent AEs Causing Study Medication Discontinuation   [ Time Frame: Weeks 0 - 3 ]

11.  Secondary:   Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation   [ Time Frame: Weeks 0 - 3 ]

12.  Secondary:   Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation   [ Time Frame: Weeks 0 - 3 ]


  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


No publications provided


Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01458275     History of Changes
Other Study ID Numbers: SEP060-305
Study First Received: October 20, 2011
Results First Received: March 10, 2014
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration