A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01067105
• Collaborator: (none)
• Enrollment: 824
• Locations: 44
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 18.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.

Condition or Disease	Intervention/Treatment	Phase
Perennial Allergic Rhinitis	Drug: ciclesonide HFA 160 μg	Phase 3

Detailed Description

This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Design

• Study Type: Interventional
• Actual Enrollment: 824 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ciclesonide ciclesonide HFA 160 μg once daily	Drug: ciclesonide HFA 160 μg; ciclesonide HFA 160 μg once daily

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Experiencing Adverse Events (AEs) [Weeks 1-26]

2. Percentage of Subjects Experiencing Serious Adverse Events (SAEs) [Weeks 1-26]

3. Percentage of Subjects Who Discontinue Due to AEs. [Weeks 1-26]

Secondary Outcome Measures

1. Percentage of Subjects Experiencing Local Nasal AEs [Weeks 1-26]

   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.

2. Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period. [Baseline and Weeks 1-26]

   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 = mild = moderate = 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 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

3. Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period. [Baseline and Weeks 1-26]

   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 = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

4. Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. [Baseline and Months 1, 2, 3, 4, 5, and 6]

   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 = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

5. Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. [Baseline and Months 1, 2, 3, 4, 5, 6]

   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 = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

6. Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances [Weeks 0-12]

   Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.

7. Number of Devices With Actuation Consistency [Weeks 0-6 and 6-12]

   Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration

8. Percentage of Devices With Actuation Consistency [Weeks 0-6 and 6-12]

   Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration

9. Number of Devices With Major Discrepancies [Weeks 0-6 and 6-12]

   A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration

10. Percentage of Devices With Major Discrepancies [Weeks 0-6 and 6-12]

    A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration

11. Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey [Weeks 6 and 12]

    Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has successfully completed all visits of Study 060-633.

• Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.

• Subject is male or female 12 years and older.

• Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.

• Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.

2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.

3. Abstinence.

Exclusion Criteria:

• Female subject who is pregnant or lactating.

• History of physical findings of nasal pathology, including nasal polyps.

• Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergy and Asthma Specialists Group	Huntington Beach	California	United States	92647
2	California Allergy and Asthma Medical Group	Los Angeles	California	United States	90025
3	Southern California Research	Mission Viejo	California	United States	92691
4	CHOC PSF, AMC, Division of Allergy Asthma and Immunology	Orange	California	United States	92868
5	California Allergy and Asthma Medical Group	Palmdale	California	United States	93551
6	Allergy Associates Medical Group	San Diego	California	United States	92120
7	Bensch Research Associates	Stockton	California	United States	95207
8	Asthma and Allergy Associates, PC	Colorado Springs	Colorado	United States	80907
9	Storms Clinical Research Institute	Colorado Springs	Colorado	United States	80907
10	Colorado Allergy and Asthma Centers	Denver	Colorado	United States	80230
11	DataQuest Medical Research	Lawrenceville	Georgia	United States	30046
12	Allergy and Asthma Consultants	Lilburn	Georgia	United States	30047
13	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
14	Clinical Research Atlanta	Stockbridge	Georgia	United States	30342
15	Atlanta Allergy and Asthma Clinic	Woodstock	Georgia	United States	30188
16	Clinical Research Center of Indiana	Indianapolis	Indiana	United States	46208
17	GR	Bethesda	Maryland	United States	20814
18	Northeast Medical Research Associates, Inc.	North Dartmouth	Massachusetts	United States	02747
19	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan	United States	48197
20	The Clinical Research Center	St. Louis	Missouri	United States	63141
21	Clinical Research Group of Montana	Bozeman	Montana	United States	59718
22	Allergy and Asthma Center of NC	High Point	North Carolina	United States	27262
23	North Carolina Clinical Research	Raleigh	North Carolina	United States	27607
24	Toledo Center for Clinical Research	Sylvania	Ohio	United States	43560
25	Allergy and Ashtma Research Group	Eugene	Oregon	United States	97401
26	Baker Allergy, Asthma, and Dermatology Research Center	Lake Oswego	Oregon	United States	97035
27	Allergy Associates Research Center	Portland	Oregon	United States	977213
28	Valley Clinical Research	Bethlehem	Pennsylvania	United States	18020
29	Asthma and Allergy Research	Upland	Pennsylvania	United States	19013
30	Asthma, Nasal Disease, and Allergy Research Center of New England	Providence	Rhode Island	United States	02906
31	National Allergy, Asthma, and Urticaria Centers	Charleston	South Carolina	United States	29406
32	ISIS Clinical Research	Austin	Texas	United States	78731
33	Sirius Clinical Research	Austin	Texas	United States	78759
34	TTS Research	Boerne	Texas	United States	78006
35	Pharmaceutical Research and Consulting	Dallas	Texas	United States	75231
36	North Texas Institute for Clinical Trials	Fort Worth	Texas	United States	76132
37	Allergy and Asthma Associates	Houston	Texas	United States	77054
38	Kerrville Research Associates	Kerrville	Texas	United States	78028
39	Central Texas Health Research	New Braunfels	Texas	United States	78130
40	Western Sky Medical Research	Paso	Texas	United States	79903
41	Biogenics Research Institute	San Antonio	Texas	United States	78229
42	Southwest Allergy and Asthma Center	San Antonio	Texas	United States	78229
43	Sylvana Research	San Antonio	Texas	United States	78229
44	ASTHMA Inc.	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Sunovion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT01067105
• Other Study ID Numbers: 060-635
• First Posted: Feb 11, 2010
• Last Update Posted: Jun 13, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Sunovion: Perennial allergic rhinitis; allergic rhinitis; ciclesonide
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Ciclesonide

Study Results

Participant Flow

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Period Title: Overall Study
STARTED	824
COMPLETED	683
NOT COMPLETED	141

Baseline Characteristics

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Overall Participants	824
Age (Count of Participants)
<=18 years	64 7.8%
Between 18 and 65 years	743 90.2%
>=65 years	17 2.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.5 (13.2)
Sex: Female, Male (Count of Participants)
Female	529 64.2%
Male	295 35.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	160 19.4%
Not Hispanic or Latino	664 80.6%
Unknown or Not Reported	0 0%
Race/Ethnicity (participants) [Number]
White/Caucasian	690 83.7%
Black or African American	104 12.6%
Asian	15 1.8%
American Indian or Alaska Native	1 0.1%
Native Hawaiian or Other Pacific Islander	3 0.4%
Other	7 0.8%
Multiple	4 0.5%
Baseline AM Reflective Total Nasal Symptom Score (rTNSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.66 (3.07)
Baseline AM Instantaneous Total Nasal Symptom Score (iTNSS) (units on a scale) [Median (Standard Deviation) ]
Median (Standard Deviation) [units on a scale]	5.12 (3.05)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Experiencing Adverse Events (AEs)
Time Frame	Weeks 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Number [percentage of participants]	51.5 6.3%

2. Primary Outcome

Title	Percentage of Subjects Experiencing Serious Adverse Events (SAEs)
Time Frame	Weeks 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Number [percentage of participants]	1.8 0.2%

3. Primary Outcome

Title	Percentage of Subjects Who Discontinue Due to AEs.
Time Frame	Weeks 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Number [percentage of participants]	1.7 0.2%

4. Secondary Outcome

Title	Percentage of Subjects Experiencing Local Nasal AEs
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 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Number [percentage of participants]	29.4 3.6%

5. Secondary Outcome

Title	Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.
Description	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent = mild = moderate = 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 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame	Baseline and Weeks 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population. Subjects with missing date were not included in the analysis.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	823
Mean (Standard Deviation) [units on a scale]	-0.50 (1.46)

6. Secondary Outcome

Title	Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.
Description	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame	Baseline and Weeks 1-26

Outcome Measure Data

Analysis Population Description

Intent to Treat Population. Subjects with missing date were not included in the analysis.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	823
Mean (Standard Deviation) [units on a scale]	-0.54 (1.37)

7. Secondary Outcome

Title	Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.
Description	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame	Baseline and Months 1, 2, 3, 4, 5, and 6

Outcome Measure Data

Analysis Population Description

Intent to Treat Population. Subjects with missing date were not included in the analysis.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	823
Month 1 (n=823)	-0.18 (1.26)
Month 2 (n=806)	-0.48 (1.49)
Month 3 (n=768)	-0.64 (1.57)
Month 4 (n=743)	-0.69 (1.70)
Month 5 (n=716)	-0.64 (1.77)
Month 6 (n=697)	-0.54 (1.87)

8. Secondary Outcome

Title	Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.
Description	TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent = mild = moderate = 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 month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.
Time Frame	Baseline and Months 1, 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description

Intent to Treat Population. Subjects with missing date were not included in the analysis.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	823
Month 1 (n=823)	-0.26 (1.16)
Month 2 (n=806)	-0.55 (1.41)
Month 3 (n=768)	-0.66 (1.47)
Month 4 (n=743)	-0.70 (1.57)
Month 5 (n=716)	-0.67 (1.68)
Month 6 (n=697)	-0.57 (1.73)

9. Secondary Outcome

Title	Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances
Description	Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.
Time Frame	Weeks 0-12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 0-6 (n=778)	112.29 (23.64)
Week 6-12 (n=732)	112.23 (23.72)

10. Secondary Outcome

Title	Number of Devices With Actuation Consistency
Description	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Time Frame	Weeks 0-6 and 6-12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population.

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 0-6	556
Week 6-12	531

11. Secondary Outcome

Title	Percentage of Devices With Actuation Consistency
Description	Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration
Time Frame	Weeks 0-6 and 6-12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 0-6	71.5
Week 6-12	72.5

12. Secondary Outcome

Title	Number of Devices With Major Discrepancies
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	Weeks 0-6 and 6-12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 0-6	144
Week 6-12	117

13. Secondary Outcome

Title	Percentage of Devices With Major Discrepancies
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	Weeks 0-6 and 6-12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 0-6	18.5
Week 6-12	16.0

14. Secondary Outcome

Title	Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey
Description	Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.
Time Frame	Weeks 6 and 12

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
Measure Participants	824
Week 6	794 96.4%
Week 12	744 90.3%

Adverse Events

Arm/Group Title	Ciclesonide
Arm/Group Description	ciclesonide HFA 160 μg once daily
All Cause Mortality
	Ciclesonide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ciclesonide
	Affected / at Risk (%)	# Events
Total	15/824 (1.8%)
Cardiac disorders
Artrial flutter	1/824 (0.1%)	1
Cardiac failure congestive	1/824 (0.1%)	1
Gastrointestinal disorders
Gastrooesophageal reflux disease	1/824 (0.1%)	1
Peritonitis	1/824 (0.1%)	1
General disorders
Chest pain	1/824 (0.1%)	1
Infections and infestations
Appendicitis	1/824 (0.1%)	1
Pneumonia	1/824 (0.1%)	1
Pyelonephritis acute	1/824 (0.1%)	1
Injury, poisoning and procedural complications
Overdose	1/824 (0.1%)	1
Renal injury	1/824 (0.1%)	1
Rib fracture	1/824 (0.1%)	2
Road traffic accident	1/824 (0.1%)	1
Investigations
Troponin increased	1/824 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II	1/824 (0.1%)	1
Uterine leiomyoma	1/824 (0.1%)	1
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy	1/824 (0.1%)	1
Psychiatric disorders
Mental status change	1/824 (0.1%)	1
Reproductive system and breast disorders
Endometrial hypertrophy	1/824 (0.1%)	1
Menorrhagia	1/824 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema	1/824 (0.1%)	1
Respiratory failure	1/824 (0.1%)	1
Social circumstances
Imprisonment	2/824 (0.2%)	2
Other (Not Including Serious) Adverse Events
	Ciclesonide
	Affected / at Risk (%)	# Events
Total	329/824 (39.9%)
Immune system disorders
Urinary tract infection	22/824 (2.7%)	23
Infections and infestations
Bronchitis	21/824 (2.5%)	24
Nasopharyngitis	31/824 (3.8%)	35
Sinusitis	38/824 (4.6%)	42
Upper respiratory tract infection	61/824 (7.4%)	72
Viral upper respiratory tract infection	17/824 (2.1%)	20
Musculoskeletal and connective tissue disorders
Back pain	21/824 (2.5%)	23
Nervous system disorders
Headache	39/824 (4.7%)	56
Respiratory, thoracic and mediastinal disorders
Epistaxis	46/824 (5.6%)	64
Nasal septum disorder	13/824 (1.6%)	14
Oropharyngeal pain	20/824 (2.4%)	21

Limitations/Caveats

Open label study investigating a dose higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 mcg is equivalent to 160 mcg.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.