Trial Outcomes & Findings for A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma (NCT NCT02040766)
NCT ID: NCT02040766
Last Updated: 2021-11-09
Results Overview
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Day 1 (baseline), Weeks 2, 4, 8, 12
Results posted on
2021-11-09
Participant Flow
Patients were screened at 123 centers in Croatia, Mexico, Poland, Ukraine, and the United States. The intent-to-treat (ITT) population included all randomly assigned patients
Patients were randomly assigned to treatment through a qualified randomization service provider. This system was used to ensure a balance across treatment groups, within each stratum
Participant milestones
| Measure |
Placebo BAI and MDI
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
127
|
126
|
125
|
125
|
125
|
|
Overall Study
COMPLETED
|
109
|
116
|
113
|
112
|
112
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
12
|
13
|
13
|
Reasons for withdrawal
| Measure |
Placebo BAI and MDI
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
2
|
3
|
2
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
3
|
1
|
4
|
|
Overall Study
Not reported
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
4
|
6
|
5
|
Baseline Characteristics
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
Baseline characteristics by cohort
| Measure |
BDP 80 mcg MDI
n=125 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
Placebo BAI and MDI
n=127 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=126 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=125 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=125 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.2 years
STANDARD_DEVIATION 1.78 • n=4 Participants
|
8.2 years
STANDARD_DEVIATION 2.06 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 2.10 • n=7 Participants
|
8.4 years
STANDARD_DEVIATION 1.24 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 1.86 • n=21 Participants
|
8.3 years
STANDARD_DEVIATION 1.93 • n=10 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=4 Participants
|
41 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
50 Participants
n=21 Participants
|
238 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=4 Participants
|
86 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
75 Participants
n=21 Participants
|
390 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=4 Participants
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
49 Participants
n=21 Participants
|
195 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=4 Participants
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
63 Participants
n=21 Participants
|
348 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=4 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Weeks 2, 4, 8, 12Population: The full analysis set (FAS) included all patients in the ITT population who received at least 1 dose of study drug and had at least 1 post baseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of percent predicted FEV1.
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.
Outcome measures
| Measure |
Placebo BAI and MDI
n=113 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=111 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=116 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=114 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=114 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Standardized Baseline-adjusted Trough Morning Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk))
|
2.62 liters
Standard Error 0.744
|
5.43 liters
Standard Error 0.742
|
3.25 liters
Standard Error 0.732
|
3.54 liters
Standard Error 0.734
|
3.71 liters
Standard Error 0.734
|
SECONDARY outcome
Timeframe: Day 1 (baseline), weeks 1-12Population: Full analysis set
The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF calculated across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF.
Outcome measures
| Measure |
Placebo BAI and MDI
n=124 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=124 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=122 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=121 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=123 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period
|
4.3 liters
Standard Error 2.11
|
15.6 liters
Standard Error 2.08
|
12.8 liters
Standard Error 2.12
|
11.9 liters
Standard Error 2.11
|
10.8 liters
Standard Error 2.11
|
SECONDARY outcome
Timeframe: Day 1 (baseline), weeks 1-12Population: Full analysis set
The analysis of change from baseline in the weekly average of daily evening PEF across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening PEF.
Outcome measures
| Measure |
Placebo BAI and MDI
n=124 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=124 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=122 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=121 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=123 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period
|
1.4 liters
Standard Error 2.11
|
13.1 liters
Standard Error 2.09
|
11.4 liters
Standard Error 2.12
|
11.3 liters
Standard Error 2.12
|
10.1 liters
Standard Error 2.12
|
SECONDARY outcome
Timeframe: Day 1 (baseline), weeks 1-12Population: Full analysis set
The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) across the 12 weeks was analyzed using a mixed model for repeated measures (MMRM).
Outcome measures
| Measure |
Placebo BAI and MDI
n=124 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=124 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=122 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=121 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=123 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12
|
-0.36 Number of inhalations
Standard Error 0.069
|
-0.72 Number of inhalations
Standard Error 0.068
|
-0.50 Number of inhalations
Standard Error 0.069
|
-0.41 Number of inhalations
Standard Error 0.069
|
-0.54 Number of inhalations
Standard Error 0.069
|
SECONDARY outcome
Timeframe: Day 1 (baseline), weeks 1-12Population: Full analysis set
The total daily asthma symptom score is the average of the daytime and nighttime scores analyzed using an mixed model for repeated measures (MMRM). Baseline was defined as the average of recorded morning and evening asthma symptom scores over the 7 days before randomization. Daytime Scores range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities; Nighttime Scores range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The daily asthma symptom score was therefore 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night.
Outcome measures
| Measure |
Placebo BAI and MDI
n=124 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=124 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=122 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=121 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=123 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12
|
-0.27 units on a scale
Standard Error 0.036
|
-0.44 units on a scale
Standard Error 0.036
|
-0.36 units on a scale
Standard Error 0.036
|
-0.31 units on a scale
Standard Error 0.036
|
-0.36 units on a scale
Standard Error 0.036
|
SECONDARY outcome
Timeframe: Day 1 to 12 weeksPopulation: Full analysis set
Time to withdrawal due to meeting stopping criteria was defined as number of days elapsed from the date of first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Kaplan-Meier estimates (median and 95% CI of the median) are not applicable if the proportion of participants withdrawn is less than 0.5.
Outcome measures
| Measure |
Placebo BAI and MDI
n=124 Participants
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=124 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=122 Participants
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=121 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=123 Participants
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|
|
Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period
|
NA Days
Too few participants withdrew to calculate estimate.
|
NA Days
Too few participants withdrew to calculate estimate.
|
NA Days
Too few participants withdrew to calculate estimate.
|
NA Days
Too few participants withdrew to calculate estimate.
|
NA Days
Too few participants withdrew to calculate estimate.
|
Adverse Events
Run-in Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo BAI and MDI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BDP 80 mcg BAI
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BDP 160 mcg BAI
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BDP 80 mcg MDI
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BDP 160 mcg MDI
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Run-in Placebo
n=628 participants at risk
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily. Both were single-blind therapies giving participants experience with the devices.
Prestudy asthma medications were adjusted according to the protocol.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
Placebo BAI and MDI
n=127 participants at risk
Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg BAI
n=126 participants at risk
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg BAI
n=125 participants at risk
Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day).
Placebo MDI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 80 mcg MDI
n=125 participants at risk
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
BDP 160 mcg MDI
n=125 participants at risk
Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day).
Placebo BAI twice daily for blinding.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/628 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
3.1%
4/127 • Number of events 5 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
4.0%
5/126 • Number of events 6 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
8.8%
11/125 • Number of events 14 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
4.8%
6/125 • Number of events 7 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
4.8%
6/125 • Number of events 7 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.16%
1/628 • Number of events 1 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
3.1%
4/127 • Number of events 7 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
0.79%
1/126 • Number of events 1 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
2.4%
3/125 • Number of events 3 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
7.2%
9/125 • Number of events 11 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
4.8%
6/125 • Number of events 7 • - Run-In: Days -21 to Day 0 - Double-blind Study Treatment: Day 1 to Week 12
Run-In Placebo arm includes participants who were randomized.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 215-591-3000
Email: [email protected]
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