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 >=12 Years Old With Persistent Asthma (NCT NCT02031640)
NCT ID: NCT02031640
Last Updated: 2021-11-09
Results Overview
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). 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 FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t \<12 weeks (2, 4, or 8 weeks).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1113 participants
Primary outcome timeframe
Day 1 (baseline), Weeks 2, 4, 8, 12
Results posted on
2021-11-09
Participant Flow
For this study, 125 sites were activated, 115 sites screened at least 1 patient (91 centers in the United States, 10 centers in Germany, 10 centers in Hungary, and 4 centers in Poland), and 97 sites randomized at least 1 patient.
There were two periods prior to treatment assignment: a screening period and a run-in period.
Participant milestones
| Measure |
Consented Patients - Standard ICS and Placebo
Consented patients were placed on a standard inhaled corticosteroids (ICS) of fluticasone propionate through the Screening and Run-In Periods. The assigned total daily dose was 440 mcg/day or 880 mcg/day dependent upon prestudy asthma treatment.
In addition to standard ICS, participants were provided with single-blind placebo BAI and single-blind placebo MDI device for twice-daily use during the Run-In period.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms
|
Placebo BAI and MDI
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 320 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 640 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 320 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 640 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
|---|---|---|---|---|---|---|
|
Screening Period
STARTED
|
1113
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
COMPLETED
|
701
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
412
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
STARTED
|
701
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
COMPLETED
|
532
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
NOT COMPLETED
|
169
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
STARTED
|
0
|
106
|
106
|
106
|
107
|
107
|
|
Double-blind Treatment Period
Full Analysis Set
|
0
|
106
|
104
|
106
|
106
|
107
|
|
Double-blind Treatment Period
COMPLETED
|
0
|
84
|
100
|
99
|
96
|
104
|
|
Double-blind Treatment Period
NOT COMPLETED
|
0
|
22
|
6
|
7
|
11
|
3
|
Reasons for withdrawal
| Measure |
Consented Patients - Standard ICS and Placebo
Consented patients were placed on a standard inhaled corticosteroids (ICS) of fluticasone propionate through the Screening and Run-In Periods. The assigned total daily dose was 440 mcg/day or 880 mcg/day dependent upon prestudy asthma treatment.
In addition to standard ICS, participants were provided with single-blind placebo BAI and single-blind placebo MDI device for twice-daily use during the Run-In period.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms
|
Placebo BAI and MDI
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 320 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 640 mcg BAI
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 320 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BDP 640 mcg MDI
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
|---|---|---|---|---|---|---|
|
Screening Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
Withdrawal by Subject
|
29
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
Inclusion criteria not met
|
312
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
Exclusion criteria met
|
30
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
Lost to Follow-up
|
14
|
0
|
0
|
0
|
0
|
0
|
|
Screening Period
Enrollment closed
|
26
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Adverse Event
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Withdrawal by Subject
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Inclusion criteria not met
|
38
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Exclusion criteria met
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Randomization criteria not met
|
85
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period
Various administrative reasons
|
17
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Treatment Period
Protocol deviation
|
0
|
2
|
0
|
1
|
3
|
1
|
|
Double-blind Treatment Period
Lack of Efficacy
|
0
|
14
|
3
|
2
|
5
|
1
|
|
Double-blind Treatment Period
Non-compliance
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Double-blind Treatment Period
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
0
|
2
|
3
|
1
|
1
|
1
|
|
Double-blind Treatment Period
Lost to Follow-up
|
0
|
3
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
Baseline characteristics by cohort
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
457 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
335 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
197 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
99 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
415 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Day 1 (baseline), Weeks 2, 4, 8, 12Population: Full analysis set- randomized patients with at least 1 dose of drug and 1 postbaseline trough am FEV1
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). 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 FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t \<12 weeks (2, 4, or 8 weeks).
Outcome measures
| Measure |
Placebo BAI and MDI
n=105 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )
|
0.056 Liters
Standard Error 0.0219
|
0.09 Liters
Standard Error 0.0221
|
0.101 Liters
Standard Error 0.0221
|
0.041 Liters
Standard Error 0.0217
|
0.096 Liters
Standard Error 0.0216
|
SECONDARY outcome
Timeframe: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12Population: Full Analysis Set
A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over 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, sex, age, treatment, time, and time by treatment interaction.
Outcome measures
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)
|
-5.524 Liters/minute
Standard Error 2.5944
|
5.092 Liters/minute
Standard Error 2.5625
|
2.895 Liters/minute
Standard Error 2.559
|
0.480 Liters/minute
Standard Error 2.558
|
6.988 Liters/minute
Standard Error 2.5298
|
SECONDARY outcome
Timeframe: Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12Population: Full Analysis Set
A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over 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 peak PEF, sex, age, treatment, time, and time by treatment interaction.
Outcome measures
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)
|
-4.708 Liters/minute
Standard Error 2.6503
|
4.439 Liters/minute
Standard Error 2.6199
|
4.462 Liters/minute
Standard Error 2.6092
|
-0.62 Liters/minute
Standard Error 2.6145
|
5.594 Liters/minute
Standard Error 2.5848
|
SECONDARY outcome
Timeframe: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12Population: Full analysis set
Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit. Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction.
Outcome measures
| Measure |
Placebo BAI and MDI
n=101 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=96 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=99 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=97 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=101 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
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 Using a Mixed Model for Repeated Measures (MMRM)
|
0.478 number of inhalations
Standard Error 0.1232
|
-0.226 number of inhalations
Standard Error 0.1235
|
-0.213 number of inhalations
Standard Error 0.1221
|
-0.173 number of inhalations
Standard Error 0.1246
|
-0.323 number of inhalations
Standard Error 0.1206
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12Population: Full analysis set. Analysis used a MMRM with effects due to baseline score, sex, age, time, treatment, and time-by-treatment interaction.
Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a 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. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments.
Outcome measures
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)
|
-0.058 units on a scale
Standard Error 0.0425
|
-0.207 units on a scale
Standard Error 0.0417
|
-0.159 units on a scale
Standard Error 0.0415
|
-0.247 units on a scale
Standard Error 0.0417
|
-0.274 units on a scale
Standard Error 0.0411
|
SECONDARY outcome
Timeframe: Day 1 - Week 12Population: Full analysis set; unable to calculate as few patients met stopping criteria
Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are: * FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV. * Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period: * 4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma; * 3+ days in which 12+ inhalations/day of rescue medication were used * 2+ days in which the patient experienced a nighttime asthma symptom score of more than 2 * Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization.
Outcome measures
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma
|
NA days
The median and 95% CI of the median is not applicable if the proportion of participants withdrawn is less than 0.5.
|
NA days
The median and 95% CI of the median is not applicable if the proportion of participants withdrawn is less than 0.5.
|
NA days
The median and 95% CI of the median is not applicable if the proportion of participants withdrawn is less than 0.5.
|
NA days
The median and 95% CI of the median is not applicable if the proportion of participants withdrawn is less than 0.5.
|
NA days
The median and 95% CI of the median is not applicable if the proportion of participants withdrawn is less than 0.5.
|
SECONDARY outcome
Timeframe: Treatment period: Day 1 up to Week 12Population: Full analysis set
A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of alert criteria is: * FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1). * Other criteria as defined in the protocol.
Outcome measures
| Measure |
Placebo BAI and MDI
n=106 Participants
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg BAI
n=104 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg BAI
n=106 Participants
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 320 mcg MDI
n=106 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
BDP 640 mcg MDI
n=107 Participants
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Placebo BAI for blinding.
Albuterol/salbutamol: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
|
|---|---|---|---|---|---|
|
Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
|
15 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
BDP 320 mcg BAI
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
BAI 640 mcg/Day
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
MDI 320 mcg/Day
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MDI 640 mcg/Day
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo BAI and MDI
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Run-in Period Experience for Randomized Participants
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BDP 320 mcg BAI
n=106 participants at risk
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BAI 640 mcg/Day
n=106 participants at risk
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
MDI 320 mcg/Day
n=107 participants at risk
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
MDI 640 mcg/Day
n=107 participants at risk
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
Placebo BAI and MDI
n=106 participants at risk
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
Run-in Period Experience for Randomized Participants
n=532 participants at risk
Experience of randomized participants during the Run-In Period when they were administered standard ICS (fluticasone propionate) as well as single-blind placebo BAI and single-blind placebo MDI devices for twice-daily use.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.19%
1/532 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Infections and infestations
Gastroenteritis
|
0.94%
1/106 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.93%
1/107 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.94%
1/106 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Renal and urinary disorders
Renal failure acute
|
0.94%
1/106 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.94%
1/106 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/107 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/532 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
Other adverse events
| Measure |
BDP 320 mcg BAI
n=106 participants at risk
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
BAI 640 mcg/Day
n=106 participants at risk
Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Placebo MDI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
MDI 320 mcg/Day
n=107 participants at risk
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
MDI 640 mcg/Day
n=107 participants at risk
Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. Placebo BAI for blinding. Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
Placebo BAI and MDI
n=106 participants at risk
Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms.
|
Run-in Period Experience for Randomized Participants
n=532 participants at risk
Experience of randomized participants during the Run-In Period when they were administered standard ICS (fluticasone propionate) as well as single-blind placebo BAI and single-blind placebo MDI devices for twice-daily use.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
4.7%
5/106 • Number of events 7 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
9.4%
10/106 • Number of events 12 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
2.8%
3/107 • Number of events 3 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
8.4%
9/107 • Number of events 11 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.00%
0/106 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
1.3%
7/532 • Number of events 7 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
4/106 • Number of events 4 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.94%
1/106 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
6.5%
7/107 • Number of events 7 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
3.7%
4/107 • Number of events 4 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
1.9%
2/106 • Number of events 2 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
0.19%
1/532 • Number of events 1 • - Run-In Period: Days -21 to Day 1 - Double-blind Treatment Period: Day 1 to Week 12
|
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