Trial Outcomes & Findings for Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis (NCT NCT01378429)
NCT ID: NCT01378429
Last Updated: 2014-05-26
Results Overview
Area under the concentration-time curve from time 0 to 24 hours \[AUC(0-24h)\]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
COMPLETED
PHASE3
89 participants
Week 0 and 6
2014-05-26
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo
|
Ciclesonide Nasal Aerosol
ciclesonide nasal aerosol (74 mcg)
ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
47
|
|
Overall Study
COMPLETED
|
41
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo
|
Ciclesonide Nasal Aerosol
ciclesonide nasal aerosol (74 mcg)
ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)
|
|---|---|---|
|
Overall Study
Noncompliance with study drug
|
1
|
0
|
Baseline Characteristics
Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol (74 mcg)
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 1.74 • n=5 Participants
|
8.6 years
STANDARD_DEVIATION 1.65 • n=7 Participants
|
8.9 years
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
47 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 and 6Population: The Per Protocol (PP) population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no important protocol deviations (IPDs).
Area under the concentration-time curve from time 0 to 24 hours \[AUC(0-24h)\]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=46 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period
|
5.9 mcg•hour/dL
Standard Error 5.6
|
-1.7 mcg•hour/dL
Standard Error 5.2
|
SECONDARY outcome
Timeframe: weeks 0-6Population: The PP population. Subjects with either missing baseline data or post dose data, or both were not included in the analysis
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=45 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine
|
1.4 mcg/g
Standard Error 2.9
|
3.3 mcg/g
Standard Error 2.7
|
SECONDARY outcome
Timeframe: weeks 0-6Population: The PP population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no IPDs.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=45 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine
|
0.5 mcg/g
Standard Error 1.9
|
1.2 mcg/g
Standard Error 1.8
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Number of Subjects Experiencing AEs
Any AE
|
19 participants
|
20 participants
|
|
Number of Subjects Experiencing AEs
Potentially related AE
|
6 participants
|
4 participants
|
|
Number of Subjects Experiencing AEs
Nasal (local) AEs
|
6 participants
|
5 participants
|
|
Number of Subjects Experiencing AEs
Discontinued study drug due to an AE
|
0 participants
|
0 participants
|
|
Number of Subjects Experiencing AEs
Severe AE
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing AEs
Serious AE
|
0 participants
|
0 participants
|
|
Number of Subjects Experiencing AEs
Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Percentage of Subjects Experiencing AEs
Any AE
|
45.2 percentage of participants
|
42.6 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Potentially related AE
|
14.3 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Nasal (local) AEs
|
14.3 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Discontinued study drug due to an AE
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Severe AE
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Serious AE
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing AEs
Death
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Local Treatment-Emergent Adverse Events (ITT Population)
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Overall
|
6 participants
|
5 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Epistaxis
|
2 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Mucosal erosion
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Nasal discomfort
|
1 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Postnasal drip
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Rhinitis
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Rhinorrhea
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Traumatic hemorrhage
|
1 participants
|
0 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Upper respiratory tract infection
|
0 participants
|
1 participants
|
|
Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Viral upper respiratory tract infection
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Local Treatment-Emergent Adverse Events (ITT Population)
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Viral upper respiratory tract infection
|
4.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Overall
|
14.3 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Epistaxis
|
4.8 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Mucosal erosion
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Nasal discomfort
|
2.4 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Postnasal drip
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Rhinitis
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Rhinorrhea
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Traumatic hemorrhage
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.
Upper respiratory tract infection
|
0 percentage of participants
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
AUC(0-24h)
Ciclesonide serum concentration
|
0.072 ng*hr/mL
Standard Deviation 0.261
|
—
|
|
AUC(0-24h)
Des-ciclesonide serum concentration
|
0.261 ng*hr/mL
Standard Deviation 0.139
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
Cmax (ng/mL) (PK Population)
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Maximum Observed Concentration
Ciclesonide serum concentration
|
0.012 ng/mL
Standard Deviation 0.0009
|
—
|
|
Maximum Observed Concentration
Des-ciclesonide serum concentration
|
0.029 ng/mL
Standard Deviation 0.0169
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
tmax (hour) (PK Population)
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Time to the Occurrence of Cmax
Ciclesonide serum concentration
|
1.146 Hour
Standard Deviation 0.700
|
—
|
|
Time to the Occurrence of Cmax
Des-ciclesonide serum concentration
|
2.200 Hour
Standard Deviation 1.330
|
—
|
SECONDARY outcome
Timeframe: Weeks 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
Terminal half-life (t1/2) (hour)
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Terminal Half Life (t1/2)
Ciclesonide serum concentration
|
8.194 Hour
Standard Deviation 12.448
|
—
|
|
Terminal Half Life (t1/2)
Des-ciclesonide serum concentration
|
11.727 Hour
Standard Deviation 5.864
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
CL/F liter per hour (L/hour) is the apparent clearance of the drug
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Apparent Clearance of the Drug (CL/F)
Ciclesonide serum concentration
|
1222.4 L/hour
Standard Deviation 573.99
|
—
|
|
Apparent Clearance of the Drug (CL/F)
Des-ciclesonide serum concentration
|
317.8 L/hour
Standard Deviation 190.49
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.
Vz/F Liters (L) is the apparent volume of distribution
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
Ciclesonide serum concentration
|
34831.4 L
Standard Deviation 35986.86
|
—
|
|
Apparent Volume of Distribution (Vz/F)
Des-ciclesonide serum concentration
|
6151.3 L
Standard Deviation 7999.78
|
—
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations
|
101.75 percentage of number of correct advances
Standard Deviation 9.647
|
100.73 percentage of number of correct advances
Standard Deviation 11.637
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Outcome measures
| Measure |
Placebo
n=123 Devices
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=141 Devices
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
|
112 Devices
|
126 Devices
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
Outcome measures
| Measure |
Placebo
n=123 Devices
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=141 Devices
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration
|
91.1 percentage of devices
|
89.4 percentage of devices
|
SECONDARY outcome
Timeframe: weeks 0-6Population: Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.
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
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo nasal aerosol administered once daily (1 actuation per nostril)
|
Ciclesonide Nasal Aerosol
n=47 Participants
Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
|
|---|---|---|
|
Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
|
-0.7 units on a scale
Standard Deviation 1.65
|
-1.5 units on a scale
Standard Deviation 2.04
|
Adverse Events
Placebo
Ciclesonide Nasal Aerosol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Placebo: Placebo
|
Ciclesonide Nasal Aerosol
n=47 participants at risk
ciclesonide nasal aerosol (74 mcg)
ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 3 • 0-6 weeks
|
6.4%
3/47 • Number of events 4 • 0-6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
4/42 • Number of events 5 • 0-6 weeks
|
0.00%
0/47 • 0-6 weeks
|
Additional Information
Respiratory Medical Director
Sunovion
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER