Trial Outcomes & Findings for Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR) (NCT NCT01697956)
NCT ID: NCT01697956
Last Updated: 2015-10-08
Results Overview
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.
COMPLETED
PHASE3
99 participants
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)
2015-10-08
Participant Flow
A total of 110 subjects were screened. Participants were randomly assigned to either BDP nasal aerosol (80 mcg/day) or placebo nasal aerosol in a 2:1 ratio.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
32
|
|
Overall Study
Per Protocol Population
|
66
|
31
|
|
Overall Study
COMPLETED
|
66
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
Baseline characteristics by cohort
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=66 Participants
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.
|
Placebo Nasal Aerosol
n=31 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 1.54 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 1.65 • n=7 Participants
|
9.0 years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
48 participants
n=5 Participants
|
24 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
17 participants
n=5 Participants
|
6 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
50 participants
n=5 Participants
|
21 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Weight
|
37.5 kg
STANDARD_DEVIATION 12.84 • n=5 Participants
|
34.9 kg
STANDARD_DEVIATION 12.89 • n=7 Participants
|
36.7 kg
STANDARD_DEVIATION 12.85 • n=5 Participants
|
|
Body Mass Index
|
18.8 kg/m^2
STANDARD_DEVIATION 4.01 • n=5 Participants
|
18.2 kg/m^2
STANDARD_DEVIATION 3.66 • n=7 Participants
|
18.6 kg/m^2
STANDARD_DEVIATION 3.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Per protocol (PP) population
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=66 Participants
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.
|
Placebo Nasal Aerosol
n=31 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment
|
1.04 ratio
Standard Error 1.037
|
1.10 ratio
Standard Error 1.053
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Per protocol population of participants administered BDP nasal aerosol 80 mcg/day
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=66 Participants
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.
|
Placebo Nasal Aerosol
n=66 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
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)
|
573.81 h*pg/mL
Standard Deviation 508.727
|
45.60 h*pg/mL
Standard Deviation 59.037
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=47 Participants
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.
|
Placebo Nasal Aerosol
n=4 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
|
619.06 h*pg/mL
Standard Deviation 416.035
|
200.80 h*pg/mL
Standard Deviation 69.939
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Per protocol population of participants administered BDP nasal aerosol 80 mcg/day.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=66 Participants
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.
|
Placebo Nasal Aerosol
n=66 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
|
142.68 pg/mL
Standard Deviation 77.728
|
44.65 pg/mL
Standard Deviation 36.454
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=66 Participants
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.
|
Placebo Nasal Aerosol
n=58 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)
|
1.15 hours
Standard Deviation 1.189
|
1.26 hours
Standard Deviation 3.590
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=45 Participants
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.
|
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.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)
|
0.31 1/hour
Standard Deviation 0.151
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=45 Participants
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.
|
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.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)
|
3.10 hours
Standard Deviation 2.518
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1- week 10Population: Safety population which included all randomized participants who received at least one dose of randomized study medication.
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.
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=67 Participants
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.
|
Placebo Nasal Aerosol
n=32 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
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.
|
Placebo Nasal Aerosol - Shift to Low
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (AEs)
>=1 AEs
|
22 participants
|
13 participants
|
—
|
—
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Withdrawn due to AEs
|
0 participants
|
0 participants
|
—
|
—
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Severe AEs
|
2 participants
|
1 participants
|
—
|
—
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Treatment-related AEs
|
2 participants
|
1 participants
|
—
|
—
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
>=1 SAEs
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (Day -21 to -7), End of Study (Day 42)Population: Safety population
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
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=67 Participants
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.
|
Placebo Nasal Aerosol
n=67 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
Placebo Nasal Aerosol - Shift to High
n=32 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
Placebo Nasal Aerosol - Shift to Low
n=32 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Hemaglobin (g/L)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Hematocrit (l/l)
|
0 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
MCHC (g/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
MCV (FL)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
MCH (pg)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Red blood cells (10^12/L)
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Platelets (10^9/L)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
White blood cells (10^9/L)
|
0 participants
|
9 participants
|
0 participants
|
2 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Basophils (10^9/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Eosinsphils (10^9/L)
|
2 participants
|
8 participants
|
3 participants
|
2 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Lymphocytes (10^9/L)
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Monocytes (10^9/L)
|
0 participants
|
10 participants
|
0 participants
|
5 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Neutrophils (10^9/L)
|
0 participants
|
8 participants
|
0 participants
|
4 participants
|
|
Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study
Segmented neutrophils (10^9/L)
|
0 participants
|
8 participants
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Screening (Day -21 to -7), End of Study (Day 42)Population: Safety population
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
Outcome measures
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=67 Participants
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.
|
Placebo Nasal Aerosol
n=67 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
Placebo Nasal Aerosol - Shift to High
n=32 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
Placebo Nasal Aerosol - Shift to Low
n=32 Participants
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|---|---|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Sodium (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Potassium (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Chloride (mmol/L)
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Bicarbonate (mmol/L)
|
0 participants
|
8 participants
|
0 participants
|
3 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Glucose (mmol/L)
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
BUN (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Creatinine (micromol/L)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Calcium (mmol/L)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Phosphorus (mmol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Total protein (g/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Albumin (g/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Uric acid (micromol/L)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
AST (u/L)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
ALT (u/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Alkaline phosphatase (u/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
GGT (u/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Total bilirubin (micromol/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study
Lactate dehydrogenase (u/L)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
BDP Nasal Aerosol 80 mcg/Day
Placebo Nasal Aerosol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BDP Nasal Aerosol 80 mcg/Day
n=67 participants at risk
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.
|
Placebo Nasal Aerosol
n=32 participants at risk
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
5/67 • Day 1 up to Week 10
|
3.1%
1/32 • Day 1 up to Week 10
|
|
General disorders
Pyrexia
|
7.5%
5/67 • Day 1 up to Week 10
|
3.1%
1/32 • Day 1 up to Week 10
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67 • Day 1 up to Week 10
|
6.2%
2/32 • Day 1 up to Week 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • Day 1 up to Week 10
|
6.2%
2/32 • Day 1 up to Week 10
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER