Trial Outcomes & Findings for 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 (NCT NCT01067105)

NCT ID: NCT01067105

Last Updated: 2012-06-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 824 participants
• Primary outcome timeframe: Weeks 1-26
• Results posted on: 2012-06-13

Participant Flow

Participant milestones

Measure	Ciclesonide ciclesonide HFA 160 μg once daily
Overall Study STARTED	824
Overall Study COMPLETED	683
Overall Study NOT COMPLETED	141

Reasons for withdrawal

Measure	Ciclesonide ciclesonide HFA 160 μg once daily
Overall Study Adverse Event	14
Overall Study Protocol Violation	48
Overall Study Withdrawal by Subject	36
Overall Study Lost to Follow-up	6
Overall Study Physician Decision	6
Overall Study Other	31

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Age, Categorical <=18 years	64 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	743 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age Continuous	38.5 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	529 Participants n=5 Participants
Sex: Female, Male Male	295 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	664 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity White/Caucasian	690 participants n=5 Participants
Race/Ethnicity Black or African American	104 participants n=5 Participants
Race/Ethnicity Asian	15 participants n=5 Participants
Race/Ethnicity American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity Native Hawaiian or Other Pacific Islander	3 participants n=5 Participants
Race/Ethnicity Other	7 participants n=5 Participants
Race/Ethnicity Multiple	4 participants n=5 Participants
Baseline AM Reflective Total Nasal Symptom Score (rTNSS)	5.66 units on a scale STANDARD_DEVIATION 3.07 • n=5 Participants
Baseline AM Instantaneous Total Nasal Symptom Score (iTNSS)	5.12 units on a scale STANDARD_DEVIATION 3.05 • n=5 Participants

PRIMARY outcome

Timeframe: Weeks 1-26

Population: Intent to Treat Population

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Subjects Experiencing Adverse Events (AEs)	51.5 percentage of participants

PRIMARY outcome

Timeframe: Weeks 1-26

Population: Intent to Treat Population

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Subjects Experiencing Serious Adverse Events (SAEs)	1.8 percentage of participants

PRIMARY outcome

Timeframe: Weeks 1-26

Population: Intent to Treat Population

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Subjects Who Discontinue Due to AEs.	1.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1-26

Population: Intent to Treat Population

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.

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Subjects Experiencing Local Nasal AEs	29.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1-26

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

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

Outcome measures

Measure	Ciclesonide n=823 Participants ciclesonide HFA 160 μg once daily
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.	-0.50 units on a scale Standard Deviation 1.46

SECONDARY outcome

Timeframe: Baseline and Weeks 1-26

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

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

0 = absent

1. = mild

2. = moderate

3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide n=823 Participants ciclesonide HFA 160 μg once daily
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.	-0.54 units on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 4, 5, and 6

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

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

Outcome measures

Measure	Ciclesonide n=823 Participants ciclesonide HFA 160 μg once daily
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 1 (n=823)	-0.18 units on a scale Standard Deviation 1.26
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 2 (n=806)	-0.48 units on a scale Standard Deviation 1.49
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 3 (n=768)	-0.64 units on a scale Standard Deviation 1.57
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 4 (n=743)	-0.69 units on a scale Standard Deviation 1.70
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 5 (n=716)	-0.64 units on a scale Standard Deviation 1.77
Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period. Month 6 (n=697)	-0.54 units on a scale Standard Deviation 1.87

SECONDARY outcome

Timeframe: Baseline and Months 1, 2, 3, 4, 5, 6

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

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

0 = absent

1. = mild

2. = moderate

3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.

Outcome measures

Measure	Ciclesonide n=823 Participants ciclesonide HFA 160 μg once daily
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 1 (n=823)	-0.26 units on a scale Standard Deviation 1.16
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 2 (n=806)	-0.55 units on a scale Standard Deviation 1.41
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 3 (n=768)	-0.66 units on a scale Standard Deviation 1.47
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 4 (n=743)	-0.70 units on a scale Standard Deviation 1.57
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 5 (n=716)	-0.67 units on a scale Standard Deviation 1.68
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period. Month 6 (n=697)	-0.57 units on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Weeks 0-12

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

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances Week 0-6 (n=778)	112.29 percentage of correct advances Standard Deviation 23.64
Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances Week 6-12 (n=732)	112.23 percentage of correct advances Standard Deviation 23.72

SECONDARY outcome

Timeframe: Weeks 0-6 and 6-12

Population: Intent to Treat Population.

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Number of Devices With Actuation Consistency Week 0-6	556 devices
Number of Devices With Actuation Consistency Week 6-12	531 devices

SECONDARY outcome

Timeframe: Weeks 0-6 and 6-12

Population: Intent to Treat Population

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Devices With Actuation Consistency Week 0-6	71.5 percentage of devices
Percentage of Devices With Actuation Consistency Week 6-12	72.5 percentage of devices

SECONDARY outcome

Timeframe: Weeks 0-6 and 6-12

Population: Intent to Treat Population

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Number of Devices With Major Discrepancies Week 0-6	144 devices
Number of Devices With Major Discrepancies Week 6-12	117 devices

SECONDARY outcome

Timeframe: Weeks 0-6 and 6-12

Population: Intent to Treat Population

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Percentage of Devices With Major Discrepancies Week 0-6	18.5 percentage of devices
Percentage of Devices With Major Discrepancies Week 6-12	16.0 percentage of devices

SECONDARY outcome

Timeframe: Weeks 6 and 12

Population: Intent to Treat Population

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

Outcome measures

Measure	Ciclesonide n=824 Participants ciclesonide HFA 160 μg once daily
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey Week 6	794 participants
Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey Week 12	744 participants

Adverse Events

Ciclesonide

Serious events: 15 serious events

Other events: 329 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ciclesonide n=824 participants at risk ciclesonide HFA 160 μg once daily
Cardiac disorders Artrial flutter	0.12% 1/824 • Number of events 1
Cardiac disorders Cardiac failure congestive	0.12% 1/824 • Number of events 1
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/824 • Number of events 1
Gastrointestinal disorders Peritonitis	0.12% 1/824 • Number of events 1
General disorders Chest pain	0.12% 1/824 • Number of events 1
Infections and infestations Appendicitis	0.12% 1/824 • Number of events 1
Infections and infestations Pneumonia	0.12% 1/824 • Number of events 1
Infections and infestations Pyelonephritis acute	0.12% 1/824 • Number of events 1
Injury, poisoning and procedural complications Overdose	0.12% 1/824 • Number of events 1
Injury, poisoning and procedural complications Renal injury	0.12% 1/824 • Number of events 1
Injury, poisoning and procedural complications Rib fracture	0.12% 1/824 • Number of events 2
Injury, poisoning and procedural complications Road traffic accident	0.12% 1/824 • Number of events 1
Investigations Troponin increased	0.12% 1/824 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.12% 1/824 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.12% 1/824 • Number of events 1
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.12% 1/824 • Number of events 1
Psychiatric disorders Mental status change	0.12% 1/824 • Number of events 1
Reproductive system and breast disorders Endometrial hypertrophy	0.12% 1/824 • Number of events 1
Reproductive system and breast disorders Menorrhagia	0.12% 1/824 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.12% 1/824 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 1/824 • Number of events 1
Social circumstances Imprisonment	0.24% 2/824 • Number of events 2

Other adverse events

Measure	Ciclesonide n=824 participants at risk ciclesonide HFA 160 μg once daily
Infections and infestations Bronchitis	2.5% 21/824 • Number of events 24
Infections and infestations Nasopharyngitis	3.8% 31/824 • Number of events 35
Infections and infestations Sinusitis	4.6% 38/824 • Number of events 42
Infections and infestations Upper respiratory tract infection	7.4% 61/824 • Number of events 72
Immune system disorders Urinary tract infection	2.7% 22/824 • Number of events 23
Infections and infestations Viral upper respiratory tract infection	2.1% 17/824 • Number of events 20
Musculoskeletal and connective tissue disorders Back pain	2.5% 21/824 • Number of events 23
Nervous system disorders Headache	4.7% 39/824 • Number of events 56
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 46/824 • Number of events 64
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	1.6% 13/824 • Number of events 14
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 20/824 • Number of events 21

Additional Information

Respiratory Medical Director

Sunovion

Phone: 1-866-503-6351

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER