| Primary | Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment | The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived. | Per protocol (PP) population | Posted | | Geometric Mean | Standard Error | ratio | | Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration) | | | | ID | Title | Description |
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| OG000 | BDP Nasal Aerosol 80 mcg/Day | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG001 | Placebo Nasal Aerosol | Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.04± 1.037
- OG0011.10± 1.053
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups. | | | | | ratio of BDP nasal aerosol to placebo | 0.91 | | | 2-Sided | 95 | 0.81 | 1.03 | | | | Yes | Non-Inferiority or Equivalence | |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day | Posted | | Mean | Standard Deviation | h*pg/mL | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
|---|
| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time. | Posted | | Mean | Standard Deviation | h*pg/mL | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
|---|
| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. | Posted | | Mean | Standard Deviation | pg/mL | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
|---|
| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time. | Posted | | Mean | Standard Deviation | hours | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
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| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants. | Posted | | Mean | Standard Deviation | 1/hour | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
|---|
| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP) | Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. | Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants. | Posted | | Mean | Standard Deviation | hours | | Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) | | | | ID | Title | Description |
|---|
| OG000 | 17-BMP Pharmacokinetic Parameters | PK values characterizing the active metabolite for BDP | | OG001 | BDP Pharmacokinetic Parameters | PK values characterizing beclomethasone dipropionate (BDP) |
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| Secondary | Participants With Treatment-Emergent Adverse Events (AEs) | The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities). The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out). An SAE was defined as an AE that resulted in any of the following:
- Death
- Life-threatening
- Required hospitalization or prolonged existing hospitalization
- Persistent or significant disability or incapacity
- A congenital abnormality or birth defect
- An important medical event which required medical intervention to prevent any of the above outcomes.
| Safety population which included all randomized participants who received at least one dose of randomized study medication. | Posted | | Number | | participants | | Day 1- week 10 | | | | ID | Title | Description |
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| OG000 | BDP Nasal Aerosol 80 mcg/Day | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG001 | Placebo Nasal Aerosol | Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period. |
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| Secondary | Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study | Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin | | Posted | | Number | | participants | | Screening (Day -21 to -7), End of Study (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | BDP Nasal Aerosol 80 mcg/Day - Shift to High | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG001 | BDP Nasal Aerosol 80 mcg/Day - Shift to Low | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG002 | Placebo Nasal Aerosol - Shift to High | Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period. |
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| Secondary | Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study | Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study. BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase | | Posted | | Number | | participants | | Screening (Day -21 to -7), End of Study (Day 42) | | | | ID | Title | Description |
|---|
| OG000 | BDP Nasal Aerosol 80 mcg/Day - Shift to High | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG001 | BDP Nasal Aerosol 80 mcg/Day - Shift to Low | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. | | OG002 | Placebo Nasal Aerosol - Shift to High | Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period. |
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