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Trial record 41 of 10796 for:    Placebo AND once

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

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ClinicalTrials.gov Identifier: NCT00953147
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : June 7, 2012
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 1110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description 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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day). The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Period Title: Overall Study
Started 298 505 307
Completed 261 439 265
Not Completed 37 66 42
Reason Not Completed
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
Other             4             11             13
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily Total
Hide Arm/Group Description 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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day). The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide. Total of all reporting groups
Overall Number of Baseline Participants 298 505 307 1110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
<=18 years
27
   9.1%
44
   8.7%
17
   5.5%
88
   7.9%
Between 18 and 65 years
264
  88.6%
455
  90.1%
282
  91.9%
1001
  90.2%
>=65 years
7
   2.3%
6
   1.2%
8
   2.6%
21
   1.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
37.5  (14.3) 36.5  (13.2) 38.0  (13.1) 37.2  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
Female
196
  65.8%
310
  61.4%
210
  68.4%
716
  64.5%
Male
102
  34.2%
195
  38.6%
97
  31.6%
394
  35.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
Hispanic or Latino
62
  20.8%
94
  18.6%
60
  19.5%
216
  19.5%
Not Hispanic or Latino
236
  79.2%
411
  81.4%
247
  80.5%
894
  80.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 298 participants 505 participants 307 participants 1110 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
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)
[1]
Measure Description:

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.
Baseline Instanteous Total Nasal Symptom Score (iTNSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
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)
[1]
Measure Description:

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.
Baseline Reflective Nasal Symptom Score (rNSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
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)
[1]
Measure Description:

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.
Baseline Instantaneous Nasal Symptom Score (iNSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
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)
[1]
Measure Description:

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.
Baseline Rhinoconjunctivitis Quality of Life Questionnaire score [RQLQ (S)] )≥3.0   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 298 participants 505 participants 307 participants 1110 participants
4.16  (0.77) 4.05  (0.76) 4.12  (0.78) 4.10  (0.77)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.97  (0.13) -1.82  (0.10) -1.28  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA 80 Mcg Once Daily, Placebo Once Daily
Comments The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value from primary outcome was adjusted at alpha=0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.35 to 1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA 160 Mcg Once Daily, Placebo Once Daily
Comments The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments The p-value from primary outcome was adjusted at alpha=0.025.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.24 to 0.84
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.77  (0.12) -1.60  (0.10) -1.18  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA 80 Mcg Once Daily, Placebo Once Daily
Comments Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.25 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA 160 Mcg Once Daily, Placebo Once Daily
Comments Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.12 to 0.72
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 297 503 304
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.94  (0.13) -1.78  (0.10) -1.25  (0.13)
4.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.01  (0.13) -1.88  (0.10) -1.32  (0.13)
5.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all participants analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 297 503 304
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.78  (0.12) -1.67  (0.10) -1.23  (0.12)
6.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.76  (0.13) -1.55  (0.10) -1.15  (0.13)
7.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0 - 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 297 503 304
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.51  (0.04) -0.47  (0.03) -0.31  (0.04)
Runny Nose -0.49  (0.04) -0.44  (0.03) -0.31  (0.04)
Nasal Itching -0.52  (0.04) -0.48  (0.03) -0.38  (0.04)
Nasal Congestion -0.42  (0.03) -0.38  (0.03) -0.25  (0.03)
8.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.53  (0.04) -0.52  (0.03) -0.35  (0.04)
Runny Nose -0.51  (0.04) -0.47  (0.03) -0.31  (0.04)
Nasal Itching -0.54  (0.04) -0.51  (0.03) -0.39  (0.04)
Nasal Congestion -0.43  (0.03) -0.39  (0.03) -0.26  (0.03)
9.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.
Hide Description

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. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.52  (0.04) -0.49  (0.03) -0.33  (0.04)
Runny Nose -0.50  (0.04) -0.45  (0.03) -0.31  (0.04)
Nasal Itching -0.53  (0.04) -0.49  (0.03) -0.39  (0.04)
Nasal Congestion -0.42  (0.03) -0.39  (0.03) -0.26  (0.03)
10.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Hide Description

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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 297 503 304
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.45  (0.04) -0.44  (0.03) -0.34  (0.04)
Runny Nose -0.47  (0.04) -0.43  (0.03) -0.30  (0.04)
Nasal Itching -0.51  (0.04) -0.47  (0.03) -0.37  (0.04)
Nasal Congestion -0.36  (0.03) -0.33  (0.02) -0.22  (0.03)
11.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment
Hide Description

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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 505 307
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.44  (0.04) -0.39  (0.03) -0.31  (0.04)
Runny Nose -0.47  (0.04) -0.40  (0.03) -0.29  (0.04)
Nasal Itching -0.49  (0.04) -0.45  (0.03) -0.33  (0.04)
Nasal Congestion -0.37  (0.03) -0.31  (0.03) -0.22  (0.03)
12.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period
Hide Description

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 Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 298 504 305
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Sneezing -0.44  (0.04) -0.41  (0.03) -0.32  (0.04)
Runny Nose -0.47  (0.04) -0.41  (0.03) -0.30  (0.04)
Nasal Itching -0.50  (0.04) -0.46  (0.03) -0.35  (0.04)
Nasal Congestion -0.36  (0.03) -0.32  (0.02) -0.22  (0.03)
13.Secondary Outcome
Title 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
Hide Description RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥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.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 109 191 101
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.55  (0.13) -1.27  (0.11) -0.96  (0.14)
14.Secondary Outcome
Title Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.
Hide Description RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥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.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population. Not all subjects analyzed due to missing data.
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description:
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 nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
Overall Number of Participants Analyzed 100 160 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.67  (0.14) -1.62  (0.11) -1.40  (0.15)
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/298 (2.01%)      8/505 (1.58%)      6/307 (1.95%)    
Blood and lymphatic system disorders       
Thrombocytopenia  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Cardiac disorders       
Artrioventricular block second degree  1  0/298 (0.00%)  0 0/505 (0.00%)  0 1/307 (0.33%)  1
Gastrointestinal disorders       
Diverticular perforation  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Colonic atony  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Megacolon  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Pancreatitis  1  0/298 (0.00%)  0 0/505 (0.00%)  0 2/307 (0.65%)  2
Vomiting  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
General disorders       
Hernia obstructive  1  0/298 (0.00%)  0 0/505 (0.00%)  0 1/307 (0.33%)  1
Infections and infestations       
Appendicitis  1  1/298 (0.34%)  1 0/505 (0.00%)  0 0/307 (0.00%)  0
Pneumonia  1  1/298 (0.34%)  1 0/505 (0.00%)  0 0/307 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Scleroderma  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Nervous system disorders       
Embolic cerebral infarction  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Mononeuropathy mulitplex  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Abortion spontaneous  1  1/298 (0.34%)  1 0/505 (0.00%)  0 1/307 (0.33%)  1
Psychiatric disorders       
Suicidal ideation  1  1/298 (0.34%)  1 0/505 (0.00%)  0 0/307 (0.00%)  0
Reproductive system and breast disorders       
Ovarian Cyst  1  1/298 (0.34%)  1 0/505 (0.00%)  0 0/307 (0.00%)  0
Pelvic adhesions  1  1/298 (0.34%)  1 0/505 (0.00%)  0 0/307 (0.00%)  0
Cystocele  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Rectocele  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratory failure  1  0/298 (0.00%)  0 0/505 (0.00%)  0 1/307 (0.33%)  1
Social circumstances       
Imprisonment  1  0/298 (0.00%)  0 1/505 (0.20%)  1 0/307 (0.00%)  0
Vascular disorders       
Hypertension  1  0/298 (0.00%)  0 0/505 (0.00%)  0 1/307 (0.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ciclesonide HFA 80 Mcg Once Daily Ciclesonide HFA 160 Mcg Once Daily Placebo Once Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   148/334 (44.31%)      234/475 (49.26%)      131/243 (53.91%)    
Gastrointestinal disorders       
Abdominal pain  1  4/334 (1.20%)  4 7/475 (1.47%)  8 7/243 (2.88%)  7
Nausea  1  9/334 (2.69%)  10 8/475 (1.68%)  8 2/243 (0.82%)  2
General disorders       
Instillation site discomfort  1  10/334 (2.99%)  11 9/475 (1.89%)  11 0/243 (0.00%)  0
Infections and infestations       
Bronchitis  1  7/334 (2.10%)  7 11/475 (2.32%)  11 6/243 (2.47%)  6
Influenza  1  6/334 (1.80%)  6 9/475 (1.89%)  11 3/243 (1.23%)  4
Nasopharyngitis  1  14/334 (4.19%)  17 30/475 (6.32%)  35 19/243 (7.82%)  26
Pharyngitis streptococcal  1  7/334 (2.10%)  8 5/475 (1.05%)  5 5/243 (2.06%)  6
Sinusitis  1  14/334 (4.19%)  16 27/475 (5.68%)  30 17/243 (7.00%)  18
Upper respiratory tract infection  1  43/334 (12.87%)  54 66/475 (13.89%)  74 29/243 (11.93%)  37
Urinary tract infection  1  13/334 (3.89%)  13 14/475 (2.95%)  16 9/243 (3.70%)  10
Viral upper respiratory tract infection  1  15/334 (4.49%)  16 13/475 (2.74%)  14 7/243 (2.88%)  9
Injury, poisoning and procedural complications       
Muscle strain  1  6/334 (1.80%)  7 7/475 (1.47%)  9 2/243 (0.82%)  2
Musculoskeletal and connective tissue disorders       
Back pain  1  5/334 (1.50%)  12 11/475 (2.32%)  11 10/243 (4.12%)  12
Nervous system disorders       
Headache  1  21/334 (6.29%)  36 17/475 (3.58%)  27 14/243 (5.76%)  18
Sinus headache  1  6/334 (1.80%)  10 4/475 (0.84%)  7 7/243 (2.88%)  8
Respiratory, thoracic and mediastinal disorders       
Cough  1  9/334 (2.69%)  9 19/475 (4.00%)  19 8/243 (3.29%)  9
Epistaxis  1  34/334 (10.18%)  57 57/475 (12.00%)  98 24/243 (9.88%)  42
Nasal discomfort  1  8/334 (2.40%)  9 16/475 (3.37%)  16 2/243 (0.82%)  2
Nasal mucosal disorder  1  7/334 (2.10%)  7 12/475 (2.53%)  14 2/243 (0.82%)  2
Nasal septum disorder  1  5/334 (1.50%)  6 16/475 (3.37%)  21 3/243 (1.23%)  4
Oropharyngeal pain  1  12/334 (3.59%)  15 20/475 (4.21%)  22 10/243 (4.12%)  11
Vascular disorders       
Hypertension  1  4/334 (1.20%)  4 7/475 (1.47%)  8 8/243 (3.29%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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
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.
 
Results Point of Contact
Name/Title: Respiratory Medical Director
Organization: Sunovion
Phone: 1-866-503-6351
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00953147     History of Changes
Other Study ID Numbers: 060-633
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: February 15, 2012
Results First Posted: June 7, 2012
Last Update Posted: June 13, 2012