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Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01033825
First received: December 16, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
Results First Received: February 15, 2012  
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: Perennial Allergic Rhinitis
Interventions: Drug: Ciclesonide HFA Nasal Aerosol 320 mcg
Drug: Ciclesonide HFA Nasal Aerosol 160 mcg
Drug: HFA Nasal Aerosol placebo
Drug: Ciclesonide Aqueous Nasal Spray 200 mcg
Drug: AQ Nasal Spray Placebo
Drug: Placebo plus Dexamethasone HFA
Drug: Placebo AQ plus Dexamethasone 6 mg

  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 HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo AQ Nasal Spray Placebo once daily
Placebo HFA Plus Dexamethasone 6 mg Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
Placebo AQ Plus Dexamethasone 6 mg Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.

Participant Flow:   Overall Study
    Ciclesonide HFA Nasal Aerosol 320 Mcg     Ciclesonide HFA Nasal Aerosol 160 Mcg     HFA Nasal Aerosol Placebo     Ciclesonide Aqueous Nasal Spray 200 Mcg     AQ Nasal Spray Placebo     Placebo HFA Plus Dexamethasone 6 mg     Placebo AQ Plus Dexamethasone 6 mg  
STARTED     51     60     57     48     58     18     18  
COMPLETED     48     57     55     46     56     18     18  
NOT COMPLETED     3     3     2     2     2     0     0  
Withdrawal by Subject                 2                 3                 2                 1                 1                 0                 0  
Adverse Event                 0                 0                 0                 1                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 0                 0                 0  
Unknown                 0                 0                 0                 0                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 Mcg Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo AQ Nasal Spray Placebo once daily
Placebo HFA Plus Dexamethasone 6 mg Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
Placebo AQ Plus Dexamethasone 6 mg Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
Total Total of all reporting groups

Baseline Measures
    Ciclesonide HFA Nasal Aerosol 320 Mcg     Ciclesonide HFA Nasal Aerosol 160 Mcg     HFA Nasal Aerosol Placebo     Ciclesonide Aqueous Nasal Spray 200 Mcg     AQ Nasal Spray Placebo     Placebo HFA Plus Dexamethasone 6 mg     Placebo AQ Plus Dexamethasone 6 mg     Total  
Number of Participants  
[units: participants]
 		  51     60     57     48     58     18     18     310  
Age  
[units: participants]
 		               
<=18 years     4     10     12     8     9     2     3     48  
Between 18 and 65 years     47     50     43     40     48     16     15     259  
>=65 years     0     0     2     0     1     0     0     3  
Age  
[units: years]
Mean ± Standard Deviation 		  35.8  ± 13.62     34.5  ± 13.42     33.0  ± 15.69     32.3  ± 12.53     35.5  ± 14.55     35.4  ± 12.94     34.0  ± 134.41     34.26  ± 14.01  
Gender  
[units: participants]
 		               
Female     32     37     37     30     33     6     12     187  
Male     19     23     20     18     25     12     6     123  
Ethnicity (NIH/OMB)  
[units: participants]
 		               
Hispanic or Latino     11     16     6     11     10     3     3     60  
Not Hispanic or Latino     40     44     51     37     48     15     15     250  
Unknown or Not Reported     0     0     0     0     0     0     0     0  
Race/Ethnicity, customized  
[units: particpants]
 		               
White/Caucasian     49     51     52     42     52     15     15     276  
Black or African American     1     4     5     4     5     2     1     22  
Asian     1     5     0     0     0     0     0     6  
American Indian or Alaska Native     0     0     0     1     1     0     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0     0  
Other     0     0     0     0     0     0     1     1  
Multiple     0     0     0     1     0     1     1     3  



  Outcome Measures
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1.  Primary:   Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period   [ Time Frame: week 6 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Experiencing Adverse Events (AEs)   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Subjects Experiencing Adverse Events (AEs)   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Experiencing Serious Adverse Events (SAEs).   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Subjects Experiencing Serious Adverse Events (SAEs).   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Who Discontinue Due to AEs   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Subjects Who Discontinue Due to AEs   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Experiencing Local Nasal AEs   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Subjects Experiencing Local Nasal AEs   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 10

11.  Secondary:   Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 11

12.  Secondary:   Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 12

13.  Secondary:   Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 13

14.  Secondary:   Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 14

15.  Secondary:   Baseline Daily Subject-reported AM Reflective TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 16

17.  Secondary:   Baseline Daily Subject-reported PM Reflective TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 18

19.  Secondary:   Baseline Daily Subject-reported AM Instantaneous TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 20

21.  Secondary:   Baseline Daily Subject-reported AM and PM Reflective TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 22

23.  Secondary:   Baseline Daily Subject-reported PM Instantaneous TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 24

25.  Secondary:   Baseline Daily Subject-reported AM and PM Instantaneous TNSS   [ Time Frame: Baseline ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 26

27.  Secondary:   Baseline Daily Subject-reported Individual AM Reflective NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 28

29.  Secondary:   Baseline Daily Subject-reported Individual PM Reflective NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 30

31.  Secondary:   Baseline Daily Subject-reported Individual AM and PM Reflective NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 32

33.  Secondary:   Baseline Daily Subject-reported Individual AM Instantaneous NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 33

34.  Secondary:   Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 34

35.  Secondary:   Baseline Daily Subject-reported Individual PM Instantaneous NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 35

36.  Secondary:   Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 36

37.  Secondary:   Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS   [ Time Frame: Baseline ]
  Show Outcome Measure 37

38.  Secondary:   Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 38

39.  Secondary:   Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 39

40.  Secondary:   Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.   [ Time Frame: Weeks 1-2, 2-4 ]
  Show Outcome Measure 40

41.  Secondary:   Number of Devices With Actuation Consistency   [ Time Frame: Weeks 1-4 ]
  Show Outcome Measure 41

42.  Secondary:   Percentage of Devices With Actuation Consistency   [ Time Frame: Weeks 1-4 ]
  Show Outcome Measure 42

43.  Secondary:   Number of Devices With Major Discrepancies   [ Time Frame: Week 6 ]
  Show Outcome Measure 43

44.  Secondary:   Percentage of Devices With Major Discrepancies   [ Time Frame: Week 6 ]
  Show Outcome Measure 44


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
Dose levels investigated were higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 and 282mcg are equivalent to 160 and 320mcg.  


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: NCT01033825     History of Changes
Other Study ID Numbers: 060-610
Study First Received: December 16, 2009
Results First Received: February 15, 2012
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration