Trial Outcomes & Findings for A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma (NCT NCT02040779)
NCT ID: NCT02040779
Last Updated: 2021-11-09
Results Overview
The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.
COMPLETED
PHASE3
273 participants
Baseline (Day 1 predose), weeks 2, 4, 8 and 12
2021-11-09
Participant Flow
For this study, 47 sites were activated and screened at least 1 patient, 44 sites screened at least 1 patient who entered the run-in period, and 43 sites randomly assigned a patient. Overall, 273 patients were randomly assigned to treatment
Participant milestones
| Measure |
Placebo BAI
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
90
|
92
|
|
Overall Study
Full Analysis Set (FAS)
|
90
|
88
|
92
|
|
Overall Study
COMPLETED
|
79
|
83
|
88
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo BAI
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
0
|
Baseline Characteristics
One participant did not have a height recorded
Baseline characteristics by cohort
| Measure |
Placebo BAI
n=91 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=90 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 14.82 • n=91 Participants
|
38.8 years
STANDARD_DEVIATION 15.02 • n=90 Participants
|
37.4 years
STANDARD_DEVIATION 16.05 • n=92 Participants
|
37.8 years
STANDARD_DEVIATION 15.27 • n=273 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=91 Participants
|
54 Participants
n=90 Participants
|
56 Participants
n=92 Participants
|
156 Participants
n=273 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=91 Participants
|
36 Participants
n=90 Participants
|
36 Participants
n=92 Participants
|
117 Participants
n=273 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=91 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=273 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=91 Participants
|
2 Participants
n=90 Participants
|
1 Participants
n=92 Participants
|
6 Participants
n=273 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=91 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=273 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=91 Participants
|
17 Participants
n=90 Participants
|
14 Participants
n=92 Participants
|
44 Participants
n=273 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=91 Participants
|
64 Participants
n=90 Participants
|
72 Participants
n=92 Participants
|
209 Participants
n=273 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=91 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=273 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=91 Participants
|
7 Participants
n=90 Participants
|
5 Participants
n=92 Participants
|
13 Participants
n=273 Participants
|
|
Weight
|
82.27 kg
STANDARD_DEVIATION 23.848 • n=91 Participants
|
85.30 kg
STANDARD_DEVIATION 22.382 • n=90 Participants
|
80.29 kg
STANDARD_DEVIATION 20.577 • n=92 Participants
|
82.60 kg
STANDARD_DEVIATION 22.316 • n=273 Participants
|
|
Height
|
169.28 cm
STANDARD_DEVIATION 9.473 • n=90 Participants • One participant did not have a height recorded
|
170.88 cm
STANDARD_DEVIATION 10.447 • n=90 Participants • One participant did not have a height recorded
|
168.78 cm
STANDARD_DEVIATION 8.657 • n=92 Participants • One participant did not have a height recorded
|
169.64 cm
STANDARD_DEVIATION 9.554 • n=272 Participants • One participant did not have a height recorded
|
|
Body Mass Index
|
28.383 kg/m^2
STANDARD_DEVIATION 6.9051 • n=90 Participants • One participant did not have a height recorded, therefore BMI could not be calculated.
|
29.266 kg/m^2
STANDARD_DEVIATION 7.9371 • n=90 Participants • One participant did not have a height recorded, therefore BMI could not be calculated.
|
28.136 kg/m^2
STANDARD_DEVIATION 6.7751 • n=92 Participants • One participant did not have a height recorded, therefore BMI could not be calculated.
|
28.591 kg/m^2
STANDARD_DEVIATION 7.2109 • n=272 Participants • One participant did not have a height recorded, therefore BMI could not be calculated.
|
|
Duration of Asthma
<3 months
|
0 Participants
n=91 Participants
|
0 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=273 Participants
|
|
Duration of Asthma
3 months to <6 months
|
0 Participants
n=91 Participants
|
1 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
1 Participants
n=273 Participants
|
|
Duration of Asthma
6 months to <1 year
|
1 Participants
n=91 Participants
|
1 Participants
n=90 Participants
|
0 Participants
n=92 Participants
|
2 Participants
n=273 Participants
|
|
Duration of Asthma
1 year to < 5 years
|
4 Participants
n=91 Participants
|
4 Participants
n=90 Participants
|
2 Participants
n=92 Participants
|
10 Participants
n=273 Participants
|
|
Duration of Asthma
5 years to <10 years
|
9 Participants
n=91 Participants
|
8 Participants
n=90 Participants
|
10 Participants
n=92 Participants
|
27 Participants
n=273 Participants
|
|
Duration of Asthma
10 years to <15 years
|
12 Participants
n=91 Participants
|
16 Participants
n=90 Participants
|
18 Participants
n=92 Participants
|
46 Participants
n=273 Participants
|
|
Duration of Asthma
>=15 years
|
65 Participants
n=91 Participants
|
60 Participants
n=90 Participants
|
62 Participants
n=92 Participants
|
187 Participants
n=273 Participants
|
|
Current Asthma Therapy
Inhaled corticosteroid
|
35 Participants
n=91 Participants
|
34 Participants
n=90 Participants
|
35 Participants
n=92 Participants
|
104 Participants
n=273 Participants
|
|
Current Asthma Therapy
Non-corticosteroid
|
56 Participants
n=91 Participants
|
56 Participants
n=90 Participants
|
57 Participants
n=92 Participants
|
169 Participants
n=273 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 predose), weeks 2, 4, 8 and 12Population: The full analysis set (FAS) included all patients in the intent to treat (ITT) population who received at least 1 dose of study drug and had at least 1 postbaseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of FEV1.
The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.
Outcome measures
| Measure |
Placebo BAI
n=88 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received
|
0.048 liters
Standard Error 0.0252
|
0.171 liters
Standard Error 0.0254
|
0.164 liters
Standard Error 0.0248
|
SECONDARY outcome
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12Population: Full analysis set (FAS)
Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.
Outcome measures
| Measure |
Placebo BAI
n=89 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period
|
-0.795 L/minute
Standard Error 2.8224
|
12.849 L/minute
Standard Error 2.8241
|
7.116 L/minute
Standard Error 2.7735
|
SECONDARY outcome
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up 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. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.
Outcome measures
| Measure |
Placebo BAI
n=89 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
|
-0.797 L/minute
Standard Error 3.0380
|
10.105 L/minute
Standard Error 35.0507
|
4.608 L/minute
Standard Error 2.9908
|
SECONDARY outcome
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12Population: FAS
Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction. 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 morning usage at the randomization visit.
Outcome measures
| Measure |
Placebo BAI
n=86 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=89 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12
|
-0.010 inhalations
Standard Error 0.1162
|
-0.368 inhalations
Standard Error 0.1155
|
-0.398 inhalations
Standard Error 0.1153
|
SECONDARY outcome
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12Population: Full analysis set
Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,
Outcome measures
| Measure |
Placebo BAI
n=90 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period
|
-0.166 units on a scale
Standard Error 0.0460
|
-0.293 units on a scale
Standard Error 0.0463
|
-0.304 units on a scale
Standard Error 0.0454
|
SECONDARY outcome
Timeframe: Treatment period: daily from Day 1 up to Week 12Population: Full analysis set
The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal 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
n=90 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
|
NA days
Insufficient number of participants withdrawn
|
NA days
Insufficient number of participants withdrawn
|
NA days
Insufficient number of participants withdrawn
|
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
n=90 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=88 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
|
5 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 12Population: The safety population included all randomly assigned patients (ITT population) who took 1 or more doses of study drug. In this population, treatment was assigned based upon the treatment patients actually received, regardless of the treatment to which they were randomized.
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.
Outcome measures
| Measure |
Placebo BAI
n=91 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=90 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
>=1 adverse event
|
28 Participants
|
32 Participants
|
26 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
>=1 severe TEAE
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
>=1 treatment-related TEAE
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
>=1 serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
>=1 AE causing discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12Population: Safety population
Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are: * Sitting systolic BP (low); \<=90 mm Hg and decrease of \>=20 mm Hg from baseline * Sitting diastolic BP (high): \>=105 mm Hg and increase of \>=15 mm Hg from baseline Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose).
Outcome measures
| Measure |
Placebo BAI
n=91 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=90 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
>=1 abnormality
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
Sitting systolic BP (low)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
Sitting diastolic BP (high)
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visits at weeks 2, 4, 8, 12Population: Safety population
Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.
Outcome measures
| Measure |
Placebo BAI
n=91 Participants
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=90 Participants
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 Participants
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Participants With Findings During Oropharyngeal Examination During Treatment
>=1 evidence of oral candidiasis appearance
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Participants With Findings During Oropharyngeal Examination During Treatment
Participants with a positive culture
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo BAI
BDP 80 mcg BAI
BDP 160 mcg BAI
Serious adverse events
| Measure |
Placebo BAI
n=91 participants at risk
Placebo breath-actuated inhaler (BAI) twice daily.
|
BDP 80 mcg BAI
n=90 participants at risk
40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.
|
BDP 160 mcg BAI
n=92 participants at risk
80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.1%
1/91 • Number of events 1 • Day 1 to Week 12
|
0.00%
0/90 • Day 1 to Week 12
|
0.00%
0/92 • Day 1 to Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/91 • Number of events 1 • Day 1 to Week 12
|
0.00%
0/90 • Day 1 to Week 12
|
0.00%
0/92 • Day 1 to Week 12
|
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D
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