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A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00953147
First received: August 4, 2009
Last updated: June 7, 2012
Last verified: June 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
Conditions: Allergic Rhinitis
Perennial Allergic Rhinitis
Interventions: Drug: Ciclesonide HFA 80 mcg
Drug: Ciclesonide HFA 160 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
No text entered.

Reporting Groups
  Description
Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
Ciclesonide HFA 160 Mcg Once Daily Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
Placebo Once Daily The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.

Participant Flow:   Overall Study
    Ciclesonide HFA 80 Mcg Once Daily     Ciclesonide HFA 160 Mcg Once Daily     Placebo Once Daily  
STARTED     298     505     307  
COMPLETED     261     439     265  
NOT COMPLETED     37     66     42  
Adverse Event                 8                 16                 6  
Protocol Violation                 2                 8                 4  
Withdrawal by Subject                 13                 15                 12  
Lost to Follow-up                 8                 9                 4  
Physician Decision                 2                 7                 3  
Unknown                 4                 11                 13  



  Baseline Characteristics
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Reporting Groups
  Description
Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
Ciclesonide HFA 160 Mcg Once Daily Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
Placebo Once Daily The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Total Total of all reporting groups

Baseline Measures
    Ciclesonide HFA 80 Mcg Once Daily     Ciclesonide HFA 160 Mcg Once Daily     Placebo Once Daily     Total  
Number of Participants  
[units: participants]
 		  298     505     307     1110  
Age  
[units: participants]
 		       
<=18 years     27     44     17     88  
Between 18 and 65 years     264     455     282     1001  
>=65 years     7     6     8     21  
Age  
[units: years]
Mean ± Standard Deviation 		  37.5  ± 14.3     36.5  ± 13.2     38.0  ± 13.1     37.2  ± 13.5  
Gender  
[units: participants]
 		       
Female     196     310     210     716  
Male     102     195     97     394  
Ethnicity (NIH/OMB)  
[units: participants]
 		       
Hispanic or Latino     62     94     60     216  
Not Hispanic or Latino     236     411     247     894  
Unknown or Not Reported     0     0     0     0  
Race/Ethnicity  
[units: participants]
 		       
White/Caucasian     249     420     253     922  
Black or African American     40     65     41     146  
Asian     3     5     10     18  
American Indian or Alaska Native     2     0     0     2  
Native Hawaiian or Other Pacific Islander     0     4     0     4  
Other     3     6     3     12  
Multiple     1     5     0     6  
Baseline Reflective Total Nasal Symptom Score (rTNSS) [1]
[units: units on a scale]
Mean ± Standard Deviation 		       
AM     8.51  ± 1.89     8.48  ± 1.88     8.60  ± 1.96     8.52  ± 1.90  
PM     8.53  ± 1.91     8.54  ± 1.84     8.64  ± 1.92     8.57  ± 1.88  
AM and PM     8.53  ± 1.82     8.50  ± 1.81     8.62  ± 1.88     8.54  ± 1.83  
Baseline Instanteous Total Nasal Symptom Score (iTNSS) [2]
[units: units on a scale]
Mean ± Standard Deviation 		       
AM     7.93  ± 2.27     7.89  ± 2.24     8.01  ± 2.37     7.93  ± 2.29  
PM     7.38  ± 2.43     7.38  ± 2.41     7.39  ± 2.55     7.38  ± 2.46  
AM and PM     7.66  ± 2.28     7.64  ± 2.27     7.70  ± 2.38     7.66  ± 2.30  
Baseline Reflective Nasal Symptom Score (rNSS) [3]
[units: units on a scale]
Mean ± Standard Deviation 		       
AM Sneezing     1.73  ± 0.73     1.71  ± 0.72     1.75  ± 0.74     1.73  ± 0.73  
AM Runny Nose     2.24  ± 0.59     2.22  ± 0.59     2.28  ± 0.60     2.24  ± 0.59  
AM Nasal Itching     2.06  ± 0.64     2.08  ± 0.62     2.09  ± 0.69     2.08  ± 0.64  
AM Nasal Congestion     2.48  ± 0.49     2.46  ± 0.49     2.47  ± 0.53     2.47  ± 0.50  
PM Sneezing     1.81  ± 0.68     1.81  ± 0.70     1.88  ± 0.69     1.83  ± 0.69  
PM Runny Nose     2.23  ± 0.59     2.23  ± 0.60     2.27  ± 0.60     2.24  ± 0.60  
PM Nasal Itching     2.08  ± 0.64     2.12  ± 0.60     2.12  ± 0.69     2.11  ± 0.64  
PM Nasal Congestion     2.42  ± 0.53     2.38  ± 0.52     2.38  ± 0.54     2.39  ± 0.53  
AM and PM Sneezing     1.77  ± 0.68     1.76  ± 0.69     1.81  ± 0.69     1.78  ± 0.69  
AM and PM Runny Nose     2.24  ± 0.56     2.22  ± 0.58     2.27  ± 0.58     2.24  ± 0.57  
AM and PM Nasal Itching     2.07  ± 0.62     2.10  ± 0.60     2.11  ± 0.67     2.09  ± 0.62  
AM and PM Nasal Congestion     2.45  ± 0.48     2.42  ± 0.48     2.42  ± 0.51     2.43  ± 0.49  
Baseline Instantaneous Nasal Symptom Score (iNSS) [4]
[units: units on a scale]
Mean ± Standard Deviation 		       
AM Sneezing     1.38  ± 0.91     1.40  ± 0.88     1.43  ± 0.93     1.40  ± 0.91  
AM Runny Nose     2.14  ± 0.68     2.13  ± 0.68     2.20  ± 0.67     2.15  ± 0.68  
AM Nasal Itching     2.00  ± 0.72     1.99  ± 0.69     2.00  ± 0.76     2.00  ± 0.72  
AM Nasal Congestion     2.41  ± 0.53     2.38  ± 0.56     2.38  ± 0.60     2.39  ± 0.57  
PM Sneezing     1.30  ± 0.90     1.32  ± 0.89     1.36  ± 0.90     1.32  ± 0.90  
PM Runny Nose     1.98  ± 0.73     1.98  ± 0.74     2.02  ± 0.72     1.99  ± 0.73  
PM Nasal Itching     1.87  ± 0.73     1.90  ± 0.71     1.83  ± 0.80     1.87  ± 0.74  
PM Nasal Congestion     2.22  ± 0.61     2.19  ± 0.63     2.17  ± 0.66     2.19  ± 0.63  
AM and PM Sneezing     1.35  ± 0.89     1.36  ± 0.86     1.39  ± 0.89     1.36  ± 0.88  
AM and PM Runny Nose     2.06  ± 0.67     2.05  ± 0.68     2.11  ± 0.65     2.07  ± 0.67  
AM and PM Nasal Itching     1.94  ± 0.70     1.95  ± 0.68     1.91  ± 0.75     1.93  ± 0.70  
AM and PM Nasal Congestion     2.32  ± 0.54     2.28  ± 0.57     2.28  ± 0.60     2.29  ± 0.57  
Baseline Rhinoconjunctivitis Quality of Life Questionnaire score [RQLQ (S)] )≥3.0 [5]
[units: units on a scale]
Mean ± Standard Deviation 		  4.16  ± 0.77     4.05  ± 0.76     4.12  ± 0.78     4.10  ± 0.77  
[1]

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent

  1. = mild
  2. = moderate
  3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.
[2]

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent

  1. = mild
  2. = moderate
  3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.
[3]

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:

0 = absent

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.
[4]

NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.
[5] Baseline Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)] Score in Subjects with baseline RQLQ(S) ≥3.0. RQLQ(s)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.



  Outcome Measures
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1.  Primary:   Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 5

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

7.  Secondary:   Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment   [ Time Frame: Weeks 0 - 6 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period   [ Time Frame: Weeks 0-6 ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0   [ Time Frame: Baseline and Week 6 ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.   [ Time Frame: Baseline and Week 26 ]
  Show Outcome Measure 14


  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
This study was not designed or powered for a comparison of the 80mcg dose with the 160mcg dose therefore no statistical comparisons were planned between the two active groups. Publication references to 74 and 148mcg are equivalent to 80 and 160mcg  


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: NCT00953147     History of Changes
Other Study ID Numbers: 060-633
Study First Received: August 4, 2009
Results First Received: February 15, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration