Trial Outcomes & Findings for Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422) (NCT NCT00458835)
NCT ID: NCT00458835
Last Updated: 2023-02-09
Results Overview
The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal spray could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.
Results posted on
2023-02-09
Participant Flow
This is a 3-period crossover study of 30 subjects total; There were three single dose treatment periods separated by a washout of 7-14 days.
Participant milestones
| Measure |
Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI
Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
|
Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray
Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray.
|
Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol
Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
|
Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol
Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
|
Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI
Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
|
Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray
Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, Ciclesonide 300 mcg intranasally via aqueous nasal spray.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Baseline characteristics by cohort
| Measure |
Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI
n=5 Participants
Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
|
Ciclesonide Nasal Aerosol, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray
n=5 Participants
Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray.
|
Ciclesonide HFA MDI, Then Ciclesonide Nasal Spray, Then Ciclesonide Nasal Aerosol
n=5 Participants
Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
|
Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol
n=5 Participants
Participants first received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After a 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI. After another 7-14 days washout period, they then received Ciclesonide 300 mcg via HFA nasal aerosol.
|
Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray, Then Ciclesonide HFA MDI
n=5 Participants
Participants first received Ciclesonide 300 mcg via HFA nasal aerosol. After a 7-14 days washout period, they then received Ciclesonide 300 mcg intranasally via aqueous nasal spray. After another 7-14 days washout period, they then received Ciclesonide 320 mcg orally inhaled via HFA MDI.
|
Ciclesonide HFA MDI, Then Ciclesonide Nasal Aerosol, Then Ciclesonide Nasal Spray
n=5 Participants
Participants first received Ciclesonide 320 mcg orally inhaled via HFA MDI. After a 7-14 days washout period, they then received they then received Ciclesonide 300 mcg via HFA nasal aerosol. After another 7-14 days washout period, Ciclesonide 300 mcg intranasally via aqueous nasal spray.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 4.75 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 7.24 • n=4 Participants
|
38 years
STANDARD_DEVIATION 14.09 • n=21 Participants
|
33.8 years
STANDARD_DEVIATION 8.58 • n=10 Participants
|
35.90 years
STANDARD_DEVIATION 11.95 • n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=10 Participants
|
30 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.Population: A total of 30 healthy volunteers were randomized in the study. Thirty were included in the ITT population; 29 subjects were included in the PP population. All 30 were included in the safety population. A subject was completely excluded from PP analyses as a major violation (common cold) and also due to the number of scheduled blood sample collections that could not be obtained subsequent to this subject's request for premature termination from the study.
The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal spray could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ.
Outcome measures
| Measure |
Ciclesonide Nasal Spray
n=29 Participants
Ciclesonide 300 mcg intranasally via aqueous nasal spray
|
Ciclesonide Nasal Aerosol
n=29 Participants
Ciclesonide 300 mcg intranasally via HFA nasal aerosol
|
Ciclesonide HFA MDI
n=29 Participants
Ciclesonide 320 mcg orally inhaled via HFA MDI
|
|---|---|---|---|
|
Comparison of Systemic Exposure Measured by AUC, ng*hr/L, (Area Under the Serum Concentration) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.
|
NA ng*hr/L
AUC could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ.
|
403.7 ng*hr/L
Interval 175.8 to 684.3
|
2762 ng*hr/L
Interval 1603.0 to 4301.0
|
SECONDARY outcome
Timeframe: 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.Population: A total of 30 healthy volunteers were randomized in the study. Thirty were included in the ITT population; 29 subjects were included in the PP population. All 30 were included in the safety population. A subject was completely excluded from PP analyses as a major violation (common cold) and also due to the number of scheduled blood sample collections that could not be obtained subsequent to this subject's request for premature termination from the study.
The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. The Cmax may be available only for a limited number of subjects. Thus the focus of statistical PK analysis will be on descriptive statistics. In particular, mean and median for Cmax will be calculated using data from subjects with Cmax above LLOQ (Lower Limit of Quantitation) and from all subjects with Cmax below LLOQ imputed by 0.
Outcome measures
| Measure |
Ciclesonide Nasal Spray
n=29 Participants
Ciclesonide 300 mcg intranasally via aqueous nasal spray
|
Ciclesonide Nasal Aerosol
n=29 Participants
Ciclesonide 300 mcg intranasally via HFA nasal aerosol
|
Ciclesonide HFA MDI
n=29 Participants
Ciclesonide 320 mcg orally inhaled via HFA MDI
|
|---|---|---|---|
|
Comparison of Systemic Exposure Measured by Cmax, pg/mL, (Highest Concentration of Drug in the Blood) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.
|
20.05 pg/mL
Interval 13.4 to 26.7
|
59.0 pg/mL
Interval 21.8 to 111.0
|
602.0 pg/mL
Interval 332.0 to 1120.0
|
Adverse Events
Ciclesonide Nasal Spray
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ciclesonide Nasal Aerosol
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ciclesonide HFA MDI
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ciclesonide Nasal Spray
n=29 participants at risk
Ciclesonide 300 mcg intranasally via aqueous nasal spray
|
Ciclesonide Nasal Aerosol
n=29 participants at risk
Ciclesonide 300 mcg intranasally via HFA nasal aerosol
|
Ciclesonide HFA MDI
n=29 participants at risk
Ciclesonide 320 mcg orally inhaled via HFA MDI
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
10.3%
3/29 • Number of events 3 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
6.9%
2/29 • Number of events 2 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Operation
|
0.00%
0/29 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
3.4%
1/29 • Number of events 1 • The study duration was about 4-6 weeks per subject consisting of: • Two screening visits, • A total of three Treatment Periods of 2 days each, • Two washout intervals of 7 (up to 14) days each, and • A Follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place