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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01033825
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : July 19, 2012
Last Update Posted : July 19, 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
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
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description Ciclesonide HFA Nasal Aerosol 320 mcg once daily Ciclesonide HFA Nasal Aerosol 160 mcg once daily HFA Nasal Aerosol Placebo once daily Ciclesonide Aqueous Nasal Spray 200 mcg once daily AQ Nasal Spray Placebo once daily 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 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.
Period Title: Overall Study
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
Reason Not Completed
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
Other             0             0             0             0             1             0             0
Arm/Group Title 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
Hide Arm/Group Description Ciclesonide HFA Nasal Aerosol 320 mcg once daily Ciclesonide HFA Nasal Aerosol 160 mcg once daily HFA Nasal Aerosol Placebo once daily Ciclesonide Aqueous Nasal Spray 200 mcg once daily AQ Nasal Spray Placebo once daily 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 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 of all reporting groups
Overall Number of Baseline Participants 51 60 57 48 58 18 18 310
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 60 participants 57 participants 48 participants 58 participants 18 participants 18 participants 310 participants
<=18 years
4
   7.8%
10
  16.7%
12
  21.1%
8
  16.7%
9
  15.5%
2
  11.1%
3
  16.7%
48
  15.5%
Between 18 and 65 years
47
  92.2%
50
  83.3%
43
  75.4%
40
  83.3%
48
  82.8%
16
  88.9%
15
  83.3%
259
  83.5%
>=65 years
0
   0.0%
0
   0.0%
2
   3.5%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
3
   1.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 60 participants 57 participants 48 participants 58 participants 18 participants 18 participants 310 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 60 participants 57 participants 48 participants 58 participants 18 participants 18 participants 310 participants
Female
32
  62.7%
37
  61.7%
37
  64.9%
30
  62.5%
33
  56.9%
6
  33.3%
12
  66.7%
187
  60.3%
Male
19
  37.3%
23
  38.3%
20
  35.1%
18
  37.5%
25
  43.1%
12
  66.7%
6
  33.3%
123
  39.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 60 participants 57 participants 48 participants 58 participants 18 participants 18 participants 310 participants
Hispanic or Latino
11
  21.6%
16
  26.7%
6
  10.5%
11
  22.9%
10
  17.2%
3
  16.7%
3
  16.7%
60
  19.4%
Not Hispanic or Latino
40
  78.4%
44
  73.3%
51
  89.5%
37
  77.1%
48
  82.8%
15
  83.3%
15
  83.3%
250
  80.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, customized  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 51 participants 60 participants 57 participants 48 participants 58 participants 18 participants 18 participants 310 participants
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
1.Primary Outcome
Title Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
Hide Description AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo Ciclesonide Aqueous Nasal Spray 200 Mcg Placebo Aqueous Nasal Spray
Hide Arm/Group Description:
Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: mcg•h/dL
183.2  (61.9) 171.7  (40.1) 173.1  (53.5) 172.8  (42.5) 179.0  (37.9)
2.Primary Outcome
Title 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
Hide Description Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).
Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo Ciclesonide Aqueous Nasal Spray 200 Mcg Placebo Aqueous Nasal Spray
Hide Arm/Group Description:
Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: mcg•h/dL
-4.6  (5.0) -2.6  (4.6) -5.0  (4.6) -11.4  (5.7) -1.0  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA Nasal Aerosol 320 Mcg, HFA Nasal Aerosol Placebo
Comments Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-13.9 to 13.0
Estimation Comments Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)<38
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ciclesonide HFA Nasal Aerosol 160 Mcg, HFA Nasal Aerosol Placebo
Comments Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-15.1 to 10.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ciclesonide Aqueous Nasal Spray 200 Mcg, Placebo Aqueous Nasal Spray
Comments Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
-4.7 to 25.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Experiencing Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population.
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo Ciclesonide Aqueous Nasal Spray 200 Mcg Placebo Aqueous Nasal Spray
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 75 48 76
Measure Type: Number
Unit of Measure: participants
23 17 23 19 29
4.Secondary Outcome
Title Percentage of Subjects Experiencing Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 75 48 76
Measure Type: Number
Unit of Measure: percentage of subjects
45.1 28.3 30.7 39.6 38.2
5.Secondary Outcome
Title Number of Subjects Experiencing Serious Adverse Events (SAEs).
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 48 57 75 47 76
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
6.Secondary Outcome
Title Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 48 57 75 47 76
Measure Type: Number
Unit of Measure: percentage of subjects
0 0 0 0 0
7.Secondary Outcome
Title Number of Subjects Who Discontinue Due to AEs
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 75 48 76
Measure Type: Number
Unit of Measure: participants
0 0 0 1 0
8.Secondary Outcome
Title Percentage of Subjects Who Discontinue Due to AEs
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 48 57 75 47 76
Measure Type: Number
Unit of Measure: percentage of subjects
0 0 0 2.1 0
9.Secondary Outcome
Title Number of Subjects Experiencing Local Nasal AEs
Hide Description Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title 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 6 mg Dexamethasone Placebo AQ Plus 6 mg Dexamethasone
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Placebo HFA plus 6 mg Dexamethasone once daily
Placebo AQ plus 6 mg Dexamethasone once daily
Overall Number of Participants Analyzed 51 60 57 48 58 18 18
Measure Type: Number
Unit of Measure: participants
21 11 8 16 11 5 1
10.Secondary Outcome
Title Percentage of Subjects Experiencing Local Nasal AEs
Hide Description Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title 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 6 mg Dexamethasone Placebo AQ Plus 6 mg Dexamethasone
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Placebo HFA plus 6 mg Dexamethasone once daily
Placebo AQ plus 6 mg Dexamethasone once daily
Overall Number of Participants Analyzed 51 60 57 48 58 18 18
Measure Type: Number
Unit of Measure: percentage of subjects
41.2 18.3 14.0 33.3 19.0 27.8 5.6
11.Secondary Outcome
Title Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: mcg•h/dL
99.8  (38.3) 95.1  (28.5) 92.0  (31.3) 91.9  (25.8) 97.2  (25.0)
12.Secondary Outcome
Title Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: mcg•h/dL
-1.0  (3.2) -1.3  (3.0) 0.5  (3.0) -5.8  (3.0) -2.9  (2.7)
13.Secondary Outcome
Title Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: mcg•h/dL
83.4  (30.2) 76.2  (24.0) 81.1  (28.7) 80.9  (26.8) 81.8  (22.8)
14.Secondary Outcome
Title Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: mcg•h/dL
-3.9  (2.9) -2.0  (2.7) -5.9  (2.7) -6.1  (3.7) 2.2  (3.4)
15.Secondary Outcome
Title Baseline Daily Subject-reported AM Reflective TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.55  (2.39) 8.03  (2.27) 7.81  (2.47) 7.91  (2.50) 7.84  (2.58)
16.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 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 symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.80  (0.29) -1.75  (0.26) -0.35  (0.27) -1.18  (0.30) -0.91  (0.28)
17.Secondary Outcome
Title Baseline Daily Subject-reported PM Reflective TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.82  (2.40) 8.39  (2.11) 7.83  (2.52) 8.13  (2.66) 8.16  (2.51)
18.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 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 symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.77  (0.30) -1.88  (0.28) -0.31  (0.28) -1.14  (0.29) -1.19  (0.26)
19.Secondary Outcome
Title Baseline Daily Subject-reported AM Instantaneous TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.91  (2.68) 7.63  (2.35) 7.37  (2.68) 7.24  (2.43) 7.19  (2.84)
20.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 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 symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.52  (0.27) -1.62  (0.25) -0.26  (0.25) -1.23  (0.29) -0.60  (0.26)
21.Secondary Outcome
Title Baseline Daily Subject-reported AM and PM Reflective TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.68  (2.33) 8.20  (2.14) 7.82  (2.45) 8.01  (2.52) 8.01  (2.49)
22.Secondary Outcome
Title 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
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.78  (0.29) -1.82  (0.27) -0.33  (0.27) -1.16  (0.29) -1.06  (0.27)
23.Secondary Outcome
Title Baseline Daily Subject-reported PM Instantaneous TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.84  (3.09) 7.60  (2.37) 7.13  (2.75) 7.38  (2.68) 7.44  (2.74)
24.Secondary Outcome
Title Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 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 symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.39  (0.28) -1.67  (0.26) -0.10  (0.26) -1.09  (0.30) -0.88  (0.28)
25.Secondary Outcome
Title Baseline Daily Subject-reported AM and PM Instantaneous TNSS
Hide Description

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom 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 Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.87  (2.84) 7.62  (2.29) 7.26  (2.67) 7.30  (2.52) 7.33  (2.74)
26.Secondary Outcome
Title Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 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 symptom 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
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.45  (0.27) -1.67  (0.25) -0.19  (0.25) -1.15  (0.29) -0.75  (0.27)
27.Secondary Outcome
Title Baseline Daily Subject-reported Individual AM Reflective NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.56  (0.83) 1.65  (0.88) 1.54  (0.89) 1.42  (0.81) 1.57  (0.93)
Baseline Runny Nose 1.99  (0.68) 2.16  (0.63) 2.15  (0.70) 2.27  (0.71) 2.06  (0.76)
Baseline Nasal Itching 1.71  (0.85) 1.89  (0.75) 1.83  (0.83) 1.85  (0.85) 1.92  (0.83)
Baseline Nasal Congestion 2.30  (0.59) 2.32  (0.57) 2.29  (0.60) 2.36  (0.66) 2.29  (0.62)
28.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.41  (0.09) -0.41  (0.08) -0.09  (0.08) -0.28  (0.08) -0.25  (0.08)
Runny Nose -0.50  (0.08) -0.50  (0.08) -0.17  (0.08) -0.36  (0.10) -0.29  (0.09)
Nasal Itching -0.40  (0.08) -0.40  (0.08) -0.05  (0.08) -0.33  (0.09) -0.25  (0.08)
Nasal Congestion -0.49  (0.07) -0.42  (0.07) -0.05  (0.07) -0.20  (0.09) -0.13  (0.08)
29.Secondary Outcome
Title Baseline Daily Subject-reported Individual PM Reflective NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.82  (0.71) 1.87  (0.76) 1.69  (0.81) 1.59  (0.83) 1.74  (0.87)
Baseline Runny Nose 2.03  (0.66) 2.20  (0.58) 2.11  (0.71) 2.30  (0.74) 2.16  (0.73)
Baseline Nasal Itching 1.75  (0.83) 2.02  (0.75) 1.80  (0.82) 1.93  (0.87) 2.00  (0.78)
Baseline Nasal Congestion 2.23  (0.72) 2.30  (0.54) 2.23  (0.67) 2.31  (0.73) 2.25  (0.63)
30.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.45  (0.09) -0.48  (0.08) -0.13  (0.08) -0.23  (0.08) -0.27  (0.08)
Runny Nose -0.49  (0.08) -0.48  (0.08) -0.09  (0.08) -0.37  (0.09) -0.37  (0.08)
Nasal Itching -0.38  (0.08) -0.46  (0.08) -0.05  (0.08) -0.32  (0.09) -0.34  (0.08)
Nasal Congestion -0.44  (0.08) -0.44  (0.07) -0.04  (0.07) -0.20  (0.09) -0.21  (0.08)
31.Secondary Outcome
Title Baseline Daily Subject-reported Individual AM and PM Reflective NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.69  (0.73) 1.76  (0.79) 1.62  (0.83) 1.51  (0.78) 1.66  (0.87)
Baseline Runny Nose 2.01  (0.65) 2.18  (0.59) 2.13  (0.69) 2.29  (0.70) 2.11  (0.72)
Baseline Nasal Itching 1.73  (0.83) 1.95  (0.73) 1.82  (0.80) 1.89  (0.85) 1.96  (0.79)
Baseline Nasal Congestion 2.26  (0.63) 2.31  (0.53) 2.26  (0.62) 2.33  (0.67) 2.27  (0.61)
32.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.43  (0.09) -0.45  (0.08) -0.11  (0.08) -0.25  (0.08) -0.26  (0.07)
Runny Nose -0.50  (0.08) -0.50  (0.07) -0.13  (0.08) -0.37  (0.09) -0.33  (0.08)
Nasal Itching -0.39  (0.08) -0.43  (0.08) -0.05  (0.08) -0.32  (0.09) -0.30  (0.08)
Nasal Congestion -0.47  (0.07) -0.43  (0.07) -0.04  (0.07) -0.20  (0.09) -0.17  (0.08)
33.Secondary Outcome
Title Baseline Daily Subject-reported Individual AM Instantaneous NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.24  (0.82) 1.43  (0.96) 1.34  (0.94) 1.15  (0.85) 1.30  (1.02)
Baseline Runny Nose 1.83  (0.84) 2.08  (0.66) 2.01  (0.74) 2.08  (0.68) 1.93  (0.89)
Baseline Nasal Itching 1.61  (0.86) 1.85  (0.75) 1.76  (0.89) 1.76  (0.89) 1.76  (0.91)
Baseline Nasal Congestion 2.24  (0.67) 2.27  (0.58) 2.27  (0.60) 2.25  (0.66) 2.20  (0.66)
34.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.32  (0.08) -0.37  (0.07) -0.06  (0.08) -0.24  (0.08) -0.17  (0.07)
Runny Nose -0.43  (0.08) -0.47  (0.08) -0.12  (0.08) -0.36  (0.10) -0.23  (0.09)
Nasal Itching -0.38  (0.08) -0.40  (0.07) -0.03  (0.08) -0.40  (0.09) -0.14  (0.08)
Nasal Congestion -0.41  (0.07) -0.37  (0.07) -0.05  (0.07) -0.20  (0.08) -0.06  (0.07)
35.Secondary Outcome
Title Baseline Daily Subject-reported Individual PM Instantaneous NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.42  (0.89) 1.51  (0.86) 1.40  (0.93) 1.30  (0.85) 1.47  (0.92)
Baseline Runny Nose 1.80  (0.85) 2.03  (0.73) 1.98  (0.72) 2.13  (0.75) 2.01  (0.76)
Baseline Nasal Itching 1.60  (0.90) 1.88  (0.78) 1.64  (0.84) 1.79  (0.87) 1.84  (0.91)
Baseline Nasal Congestion 2.02  (0.82) 2.19  (0.59) 2.11  (0.68) 2.16  (0.76) 2.12  (0.65)
36.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 50 59 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.33  (0.08) -0.37  (0.08) -0.07  (0.08) -0.24  (0.08) -0.22  (0.08)
Runny Nose -0.41  (0.08) -0.45  (0.07) -0.08  (0.08) -0.33  (0.10) -0.30  (0.09)
Nasal Itching -0.32  (0.08) -0.44  (0.07) 0.02  (0.07) -0.35  (0.09) -0.25  (0.08)
Nasal Congestion -0.34  (0.07) -0.39  (0.07) 0.02  (0.07) -0.15  (0.09) -0.12  (0.08)
37.Secondary Outcome
Title Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Nasal Sneezing 1.33  (0.83) 1.47  (0.89) 1.37  (0.91) 1.22  (0.83) 1.38  (0.95)
Baseline Runny Nose 1.81  (0.83) 2.05  (0.67) 2.00  (0.72) 2.10  (0.69) 1.98  (0.80)
Baseline Nasal Itching 1.61  (0.86) 1.87  (0.75) 1.70  (0.84) 1.78  (0.87) 1.80  (0.89)
Baseline Nasal Congestion 2.13  (0.72) 2.23  (0.55) 2.19  (0.62) 2.20  (0.68) 2.16  (0.63)
38.Secondary Outcome
Title Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of 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 (no sign/symptom evident);

  1. = mild
  2. = moderate
  3. = severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title 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
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
AQ Nasal Spray Placebo once daily
Overall Number of Participants Analyzed 51 60 57 48 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Nasal Sneezing -0.32  (0.08) -0.37  (0.07) -0.06  (0.07) -0.23  (0.08) -0.20  (0.07)
Runny Nose -0.42  (0.08) -0.47  (0.07) -0.10  (0.07) -0.35  (0.09) -0.27  (0.09)
Nasal Itching -0.35  (0.08) -0.42  (0.07) -0.01  (0.07) -0.37  (0.09) -0.20  (0.08)
Nasal Congestion -0.37  (0.07) -0.39  (0.06) -0.01  (0.06) -0.17  (0.08) -0.09  (0.08)
39.Secondary Outcome
Title Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
Hide Description The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.
Time Frame Weeks 0-6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide Aqueous Nasal Spray 200 Mcg
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
Overall Number of Participants Analyzed 51 60 48
Measure Type: Number
Unit of Measure: Number of days
15 29 7
40.Secondary Outcome
Title Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
Hide Description Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).
Time Frame Weeks 1-2, 2-4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Overall Number of Participants Analyzed 51 60 75
Mean (Standard Deviation)
Unit of Measure: percentage of correct advances
Weeks 1-2 (n=49,58,75) 106.3  (10.8) 106.2  (12.1) 105.3  (15.8)
Weeks 2-4 (n=46,52,71) 105.6  (11.8) 105.9  (10.5) 105.8  (11.7)
41.Secondary Outcome
Title Number of Devices With Actuation Consistency
Hide Description Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Time Frame Weeks 1-4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide Aqueous Nasal Spray 200 Mcg
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
Overall Number of Participants Analyzed 46 52 71
Measure Type: Number
Unit of Measure: Devices
42 48 68
42.Secondary Outcome
Title Percentage of Devices With Actuation Consistency
Hide Description Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.
Time Frame Weeks 1-4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Overall Number of Participants Analyzed 46 52 71
Measure Type: Number
Unit of Measure: percentage of devices
91.3 92.3 95.8
43.Secondary Outcome
Title Number of Devices With Major Discrepancies
Hide Description A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg Ciclesonide Aqueous Nasal Spray 200 Mcg
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
Ciclesonide Aqueous Nasal Spray 200 mcg once daily
Overall Number of Participants Analyzed 46 52 71
Measure Type: Number
Unit of Measure: Devices
0 2 1
44.Secondary Outcome
Title Percentage of Devices With Major Discrepancies
Hide Description A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Ciclesonide HFA Nasal Aerosol 320 Mcg Ciclesonide HFA Nasal Aerosol 160 Mcg HFA Nasal Aerosol Placebo
Hide Arm/Group Description:
Ciclesonide HFA Nasal Aerosol 320 mcg once daily
Ciclesonide HFA Nasal Aerosol 160 mcg once daily
HFA Nasal Aerosol Placebo once daily
Overall Number of Participants Analyzed 46 52 71
Measure Type: Number
Unit of Measure: percentage of devices
0 3.8 1.4
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were NOT assessed for active control (Placebo plus Dexamethasone) groups.
 
Arm/Group Title 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
Hide Arm/Group Description Ciclesonide HFA Nasal Aerosol 320 mcg once daily Ciclesonide HFA Nasal Aerosol 160 mcg once daily HFA Nasal Aerosol Placebo once daily Ciclesonide Aqueous Nasal Spray 200 mcg once daily AQ Nasal Spray Placebo once daily
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/57 (0.00%)      0/18 (0.00%)      0/47 (0.00%)      0/57 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/51 (47.06%)      22/60 (36.67%)      16/57 (28.07%)      25/48 (52.08%)      22/58 (37.93%)    
Ear and labyrinth disorders           
Vertigo  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Endocrine disorders           
Hyphthyroidism  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Eye disorders           
Conjunctivitis  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain upper  1  0/51 (0.00%)  0 0/60 (0.00%)  0 1/57 (1.75%)  1 1/48 (2.08%)  2 0/58 (0.00%)  0
Constipation  1  0/51 (0.00%)  0 0/60 (0.00%)  0 1/57 (1.75%)  1 1/48 (2.08%)  1 0/58 (0.00%)  0
Dental caries  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Diarrhoea  1  1/51 (1.96%)  1 1/60 (1.67%)  1 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Dyspepsia  1  1/51 (1.96%)  1 1/60 (1.67%)  1 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Nausea  1  1/51 (1.96%)  1 2/60 (3.33%)  2 2/57 (3.51%)  2 2/48 (4.17%)  2 2/58 (3.45%)  2
Tooth impacted  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Vomiting  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 3/48 (6.25%)  3 0/58 (0.00%)  0
General disorders           
Asthenia  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Influenza like illness  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Instillation site discomfort  1  2/51 (3.92%)  2 2/60 (3.33%)  2 1/57 (1.75%)  1 0/48 (0.00%)  0 0/58 (0.00%)  0
Pyrexia  1  1/51 (1.96%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Infections and infestations           
Eye infection  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Gastroenteritis  1  0/51 (0.00%)  0 2/60 (3.33%)  2 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Nasopharyngitis  1  4/51 (7.84%)  4 2/60 (3.33%)  2 2/57 (3.51%)  2 1/48 (2.08%)  1 3/58 (5.17%)  3
Otitis Media  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 2/48 (4.17%)  2 0/58 (0.00%)  0
Sinusitis  1  0/51 (0.00%)  0 1/60 (1.67%)  1 1/57 (1.75%)  1 1/48 (2.08%)  1 0/58 (0.00%)  0
Tooth infection  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Upper respiratory tract infection  1  1/51 (1.96%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Urinary Tract Infection  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 0/48 (0.00%)  0 1/58 (1.72%)  1
Injury, poisoning and procedural complications           
Arthropod bite  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Procedural Pain  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Fluid retention  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 2/48 (4.17%)  2 2/58 (3.45%)  2
Joint Swelling  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Myaglia  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Pain in extremity  1  1/51 (1.96%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/51 (0.00%)  0 1/60 (1.67%)  1 1/57 (1.75%)  1 1/48 (2.08%)  1 1/58 (1.72%)  1
Drug withdrawal headache  1  1/51 (1.96%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Headache  1  2/51 (3.92%)  2 2/60 (3.33%)  2 3/57 (5.26%)  3 4/48 (8.33%)  4 7/58 (12.07%)  11
Sinus Headache  1  1/51 (1.96%)  2 0/60 (0.00%)  0 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Somnolence  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 0/48 (0.00%)  0 1/58 (1.72%)  1
Psychiatric disorders           
Depression  1  0/51 (0.00%)  0 2/60 (3.33%)  3 0/57 (0.00%)  0 0/48 (0.00%)  0 0/58 (0.00%)  0
Insomnia  1  0/51 (0.00%)  0 1/60 (1.67%)  1 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Panic Attack  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 2/48 (4.17%)  2 0/58 (0.00%)  0
Epistaxis  1  12/51 (23.53%)  17 4/60 (6.67%)  7 3/57 (5.26%)  3 9/48 (18.75%)  16 3/58 (5.17%)  7
Nasal mucosal disorder  1  1/51 (1.96%)  1 0/60 (0.00%)  0 0/57 (0.00%)  0 0/48 (0.00%)  0 2/58 (3.45%)  2
Nasal septum disorder  1  2/51 (3.92%)  2 0/60 (0.00%)  0 1/57 (1.75%)  1 1/48 (2.08%)  1 2/58 (3.45%)  2
Oropharyngeal discomfort  1  0/51 (0.00%)  0 0/60 (0.00%)  0 0/57 (0.00%)  0 1/48 (2.08%)  1 0/58 (0.00%)  0
Oropharyngeal pain  1  2/51 (3.92%)  2 1/60 (1.67%)  1 0/57 (0.00%)  0 1/48 (2.08%)  1 1/58 (1.72%)  1
Skin and subcutaneous tissue disorders           
Rash  1  0/51 (0.00%)  0 0/60 (0.00%)  0 1/57 (1.75%)  1 1/48 (2.08%)  1 0/58 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
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
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Name/Title: Respiratory Medical Director
Organization: Sunovion
Phone: 1-866-503-6351
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01033825    
Other Study ID Numbers: 060-610
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: February 15, 2012
Results First Posted: July 19, 2012
Last Update Posted: July 19, 2012