Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT01401465
First received: July 21, 2011
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: ciclesonide
Drug: mometasone

  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
No text entered.

Reporting Groups
  Description
CIC / MOM Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
MOM / CIC Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    CIC / MOM     MOM / CIC  
STARTED     165     162  
COMPLETED     150     146  
NOT COMPLETED     15     16  
Adverse Event                 4                 1  
Pregnancy                 0                 1  
Protocol Violation                 5                 0  
Withdrawal by Subject                 1                 4  
Non-Compliance to Study Drug                 1                 0  
Inability to Meet Continuation Criteria                 3                 9  
Scheduling Difficulties                 1                 1  

Period 2:   Washout
    CIC / MOM     MOM / CIC  
STARTED     150     146  
COMPLETED     150     146  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2
    CIC / MOM     MOM / CIC  
STARTED     150     146  
COMPLETED     150     144  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 0                 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.
No text entered.

Reporting Groups
  Description
Sequence CIC / MOM Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
Sequence MOM / CIC Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
Total Total of all reporting groups

Baseline Measures
    Sequence CIC / MOM     Sequence MOM / CIC     Total  
Number of Participants  
[units: participants]
  165     162     327  
Age  
[units: participants]
     
<=18 years     18     24     42  
Between 18 and 65 years     143     134     277  
>=65 years     4     4     8  
Age  
[units: years]
Mean ± Standard Deviation
  37.5  ± 14.78     35.7  ± 14.72     36.6  ± 14.76  
Gender  
[units: participants]
     
Female     102     99     201  
Male     63     63     126  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     30     38     68  
Not Hispanic or Latino     135     124     259  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     0     2  
Asian     5     5     10  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     15     9     24  
White     134     144     278  
More than one race     6     3     9  
Unknown or Not Reported     3     0     3  
Region of Enrollment  
[units: participants]
     
United States     165     162     327  



  Outcome Measures
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1.  Primary:   Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items   [ Time Frame: End of Study - Day 43 ]

2.  Primary:   Change From Baseline in Regimen Attributes Composite Score   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

3.  Secondary:   Treatment Process Composite Preference Score   [ Time Frame: End of Study - Day 43 ]

4.  Secondary:   Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.   [ Time Frame: Averages over each two week treatment period ]

5.  Secondary:   Change From Baseline in the Treatment Functional Impact Composite Score   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

6.  Secondary:   Change From Baseline in the Regimen Acceptance Composite Score   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

7.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Interference   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

8.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

9.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

10.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

11.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

12.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

13.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Burden   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

14.  Secondary:   Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

15.  Secondary:   The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

16.  Secondary:   The Change From Baseline in Overall Quality of Life Composite Score   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

17.  Secondary:   The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

18.  Secondary:   The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

19.  Secondary:   The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

20.  Secondary:   The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

21.  Secondary:   The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

22.  Secondary:   The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

23.  Secondary:   The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale   [ Time Frame: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42 ]

24.  Secondary:   Treatment Outcome Composite Score Assessed at the End of the Study   [ Time Frame: End of Study - Day 43 ]

25.  Secondary:   Work/Disability Days: Bed Days   [ Time Frame: Period 1 (days 0-14), Period 2 (days 29-43) ]

26.  Secondary:   Work/Disability Days: Missed Work   [ Time Frame: Period 1 (days 0-14), Period 2 (days 29-43) ]

27.  Secondary:   Work/Disability Days: Reduced Activity Days   [ Time Frame: Period 1 (days 0-14), Period 2 (days 29-43) ]

28.  Secondary:   The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation   [ Time Frame: Over both two-week treatment periods combined ]

29.  Secondary:   The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation   [ Time Frame: Over both two-week treatment periods combined ]

30.  Secondary:   The Number of Subjects Experiencing AEs   [ Time Frame: Over both two-week treatment periods combined ]

31.  Secondary:   The Percentage of Subjects Experiencing AEs   [ Time Frame: Over both two-week treatment periods combined ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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


No publications provided by Sunovion

Publications automatically indexed to this study:

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01401465     History of Changes
Other Study ID Numbers: 060-302
Study First Received: July 21, 2011
Results First Received: November 9, 2012
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration