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The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARISâ„¢ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclesonide 300 mcg intranasally via aqueous nasal spray | Active Comparator |
| |
| Ciclesonide 300 mcg intranasally via HFA nasal aerosol | Active Comparator |
| |
| Ciclesonide 320 mcg orally inhaled via HFA MDI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARISâ„¢ [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. | 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARISâ„¢ [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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALTANA Pharma | Austin | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20110036 | Derived | Nave R, Herzog R, Laurent A, Wingertzahn MA. Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers. Clin Ther. 2009 Dec;31(12):2988-99. doi: 10.1016/j.clinthera.2009.12.002. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Comparability of treatment groups at baseline was not formally assessed. Any differences in the treatment groups at baseline were assumed to be at random.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARISâ„¢ [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. | 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. | Posted | Median | Full Range | ng*hr/L | 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciclesonide Nasal Spray | Ciclesonide 300 mcg intranasally via aqueous nasal spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Interest | Covis Pharma | 1-877-374 -4177 | CTInterest@covispharma.com |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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| 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. |
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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. | The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARISâ„¢ [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. | 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. | Posted | Median | Full Range | pg/mL | 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 4 |
| 29 |
| EG001 | Ciclesonide Nasal Aerosol | Ciclesonide 300 mcg intranasally via HFA nasal aerosol | 0 | 29 | 0 | 29 | 9 | 29 |
| EG002 | Ciclesonide HFA MDI | Ciclesonide 320 mcg orally inhaled via HFA MDI | 0 | 29 | 0 | 29 | 3 | 29 |
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chills | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus Operation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |