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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02040779
• Collaborator: (none)
• Enrollment: 273
• Locations: 47
• Arms: 3
• Duration (Months): 11.9
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Condition or Disease	Intervention/Treatment	Phase
Persistent Asthma	Drug: Beclomethasone dipropionate breath-actuated inhaler; Drug: Placebo breath-actuated inhaler; Drug: albuterol/salbutamol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
• Study Start Date: Dec 26, 2013
• Actual Primary Completion Date: Dec 24, 2014
• Actual Study Completion Date: Dec 24, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BDP 80 mcg BAI 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	Drug: Beclomethasone dipropionate breath-actuated inhaler; Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.; Other Names: BDP ; Drug: 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; Other Names: bronchodilators
Experimental: BDP 160 mcg BAI 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.	Drug: Beclomethasone dipropionate breath-actuated inhaler; Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.; Other Names: BDP ; Drug: 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; Other Names: bronchodilators
Placebo Comparator: Placebo BAI Placebo breath-actuated inhaler (BAI) twice daily.	Drug: Placebo breath-actuated inhaler; Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.; Drug: 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; Other Names: bronchodilators

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline (Day 1 predose), weeks 2, 4, 8 and 12]

   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.

Secondary Outcome Measures

1. Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period [Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12]

   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.

2. Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period [Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12]

   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.

3. Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12 [Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12]

   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.

4. Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period [Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12]

   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,

5. Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period [Treatment period: daily from Day 1 up to Week 12]

   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.

6. Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period [Treatment period: Day 1 up to Week 12]

   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.

7. Participants With Treatment-Emergent Adverse Events (TEAEs) [Day 1 up to Week 12]

   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.

8. Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period [Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12]

   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).

9. Participants With Findings During Oropharyngeal Examination During Treatment [Visits at weeks 2, 4, 8, 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).

• Current asthma therapy: The patient is currently being treated with 1 of the following:

1. inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).

• Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.

• The patient is a pregnant or lactating female or plans to become pregnant.

• The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.

• The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.

• The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.

• The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.

• Other criteria apply, please contact the investigator for more information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 12813	Huntington Beach	California	United States
2	Teva Investigational Site 10944	Mission Viejo	California	United States
3	Teva Investigational Site 10946	Orange	California	United States
4	Teva Investigational Site 10963	Rolling Hills Estates	California	United States
5	Teva Investigational Site 10960	San Diego	California	United States
6	Teva Investigational Site 10973	San Diego	California	United States
7	Teva Investigational Site 10975	San Jose	California	United States
8	Teva Investigational Site 10948	Centennial	Colorado	United States
9	Teva Investigational Site 10958	Centennial	Colorado	United States
10	Teva Investigational Site 10957	Colorado Springs	Colorado	United States
11	Teva Investigational Site 12814	Sarasota	Florida	United States
12	Teva Investigational Site 10962	Tallahassee	Florida	United States
13	Teva Investigational Site 12809	Savannah	Georgia	United States
14	Teva Investigational Site 10947	Indianapolis	Indiana	United States
15	Teva Investigational Site 10943	Iowa City	Iowa	United States
16	Teva Investigational Site 10954	Baltimore	Maryland	United States
17	Teva Investigational Site 12940	Bethesda	Maryland	United States
18	Teva Investigational Site 10955	North Dartmouth	Massachusetts	United States
19	Teva Investigational Site 10941	Minneapolis	Minnesota	United States
20	Teva Investigational Site 10970	Columbia	Missouri	United States
21	Teva Investigational Site 10968	Rolla	Missouri	United States
22	Teva Investigational Site 10972	Bozeman	Montana	United States
23	Teva Investigational Site 12941	Missoula	Montana	United States
24	Teva Investigational Site 10942	Bellevue	Nebraska	United States
25	Teva Investigational Site 10959	Skillman	New Jersey	United States
26	Teva Investigational Site 10945	Raleigh	North Carolina	United States
27	Teva Investigational Site 12810	Cincinnati	Ohio	United States
28	Teva Investigational Site 10974	Sylvania	Ohio	United States
29	Teva Investigational Site 12805	Oklahoma City	Oklahoma	United States
30	Teva Investigational Site 12942	Oklahoma City	Oklahoma	United States
31	Teva Investigational Site 10951	Tulsa	Oklahoma	United States
32	Teva Investigational Site 10940	Lake Oswego	Oregon	United States
33	Teva Investigational Site 10952	Medford	Oregon	United States
34	Teva Investigational Site 10956	Portland	Oregon	United States
35	Teva Investigational Site 12939	Pittsburgh	Pennsylvania	United States
36	Teva Investigational Site 12806	Orangeburg	South Carolina	United States
37	Teva Investigational Site 12811	Knoxville	Tennessee	United States
38	Teva Investigational Site 10969	Austin	Texas	United States
39	Teva Investigational Site 12812	Boerne	Texas	United States
40	Teva Investigational Site 10949	Dallas	Texas	United States
41	Teva Investigational Site 10953	El Paso	Texas	United States
42	Teva Investigational Site 12807	Houston	Texas	United States
43	Teva Investigational Site 10950	New Braunfels	Texas	United States
44	Teva Investigational Site 10961	San Antonio	Texas	United States
45	Teva Investigational Site 12808	Waco	Texas	United States
46	Teva Investigational Site 10967	Seattle	Washington	United States
47	Teva Investigational Site 10964	Greenfield	Wisconsin	United States

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Medical Director, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT02040779
• Other Study ID Numbers: BDB-AS-304
• First Posted: Jan 20, 2014
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.: asthma; breath-actuated inhaler; beclomethasone
• Additional relevant MeSH terms: Asthma; Beclomethasone; Albuterol; Bronchodilator Agents

Study Results

Participant Flow

Recruitment Details	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

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Period Title: Overall Study
STARTED	91	90	92
Full Analysis Set (FAS)	90	88	92
COMPLETED	79	83	88
NOT COMPLETED	12	7	4

Baseline Characteristics

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI	Total
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.	Total of all reporting groups
Overall Participants	91	90	92	273
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.2 (14.82)	38.8 (15.02)	37.4 (16.05)	37.8 (15.27)
Sex: Female, Male (Count of Participants)
Female	46 50.5%	54 60%	56 60.9%	156 57.1%
Male	45 49.5%	36 40%	36 39.1%	117 42.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 3.3%	2 2.2%	1 1.1%	6 2.2%
Native Hawaiian or Other Pacific Islander	1 1.1%	0 0%	0 0%	1 0.4%
Black or African American	13 14.3%	17 18.9%	14 15.2%	44 16.1%
White	73 80.2%	64 71.1%	72 78.3%	209 76.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.1%	7 7.8%	5 5.4%	13 4.8%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	82.27 (23.848)	85.30 (22.382)	80.29 (20.577)	82.60 (22.316)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	169.28 (9.473)	170.88 (10.447)	168.78 (8.657)	169.64 (9.554)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.383 (6.9051)	29.266 (7.9371)	28.136 (6.7751)	28.591 (7.2109)
Duration of Asthma (Count of Participants)
<3 months	0 0%	0 0%	0 0%	0 0%
3 months to <6 months	0 0%	1 1.1%	0 0%	1 0.4%
6 months to <1 year	1 1.1%	1 1.1%	0 0%	2 0.7%
1 year to < 5 years	4 4.4%	4 4.4%	2 2.2%	10 3.7%
5 years to <10 years	9 9.9%	8 8.9%	10 10.9%	27 9.9%
10 years to <15 years	12 13.2%	16 17.8%	18 19.6%	46 16.8%
>=15 years	65 71.4%	60 66.7%	62 67.4%	187 68.5%
Current Asthma Therapy (Count of Participants)
Inhaled corticosteroid	35 38.5%	34 37.8%	35 38%	104 38.1%
Non-corticosteroid	56 61.5%	56 62.2%	57 62%	169 61.9%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Baseline (Day 1 predose), weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	88	88	92
Least Squares Mean (Standard Error) [liters]	0.048 (0.0252)	0.171 (0.0254)	0.164 (0.0248)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments	A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0010
	Comments	ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	0.116
	Confidence Interval	(2-Sided) 95%; 0.048 to 0.185
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments	ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	0.124
	Confidence Interval	(2-Sided) 95%; 0.054 to 0.193
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 80 mcg BAI - Placebo BAI

2. Secondary Outcome

Title	Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period
Description	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.
Time Frame	Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS)

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	89	88	92
Least Squares Mean (Standard Error) [L/minute]	-0.795 (2.8224)	12.849 (2.8241)	7.116 (2.7735)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0443
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	7.911
	Confidence Interval	(2-Sided) 95%; 0.202 to 15.621
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	13.645
	Confidence Interval	(2-Sided) 95%; 5.843 to 21.446
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

3. Secondary Outcome

Title	Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
Description	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.
Time Frame	Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	89	88	92
Least Squares Mean (Standard Error) [L/minute]	-0.797 (3.0380)	10.105 (35.0507)	4.608 (2.9908)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2014
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	5.405
	Confidence Interval	(2-Sided) 95%; -2.905 to 13.715
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0112
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	10.902
	Confidence Interval	(2-Sided) 95%; 2.500 to 19.303
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

4. Secondary Outcome

Title	Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12
Description	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.
Time Frame	Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	86	88	89
Least Squares Mean (Standard Error) [inhalations]	-0.010 (0.1162)	-0.368 (0.1155)	-0.398 (0.1153)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0175
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	-0.388
	Confidence Interval	(2-Sided) 95%; -0.708 to -0.068
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0285
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	-0.358
	Confidence Interval	(2-Sided) 95%; -0.678 to -0.038
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 80 mcg BAI - Placebo BAI

5. Secondary Outcome

Title	Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period
Description	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,
Time Frame	Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	90	88	92
Least Squares Mean (Standard Error) [units on a scale]	-0.166 (0.0460)	-0.293 (0.0463)	-0.304 (0.0454)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0335
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	-0.137
	Confidence Interval	(2-Sided) 95%; -0.263 to -0.011
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 160 mcg BAI - Placebo BAI

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments	Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0509
	Comments	a priori threshold for significance of 0.05.
	Method	mixed model for repeated measures
	Comments
Method of Estimation	Estimation Parameter	LSM difference
	Estimated Value	-0.127
	Confidence Interval	(2-Sided) 95%; -0.255 to 0.001
	Parameter Dispersion	Type: Value:
	Estimation Comments	BDP 80 mcg BAI - Placebo BAI

6. Secondary Outcome

Title	Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
Description	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.
Time Frame	Treatment period: daily from Day 1 up to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	90	88	92
Median (95% Confidence Interval) [days]	NA	NA	NA

7. Secondary Outcome

Title	Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
Description	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.
Time Frame	Treatment period: Day 1 up to Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	90	88	92
Count of Participants [Participants]	5 5.5%	2 2.2%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 80 mcg BAI
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2384
	Comments
	Method	Log Rank
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo BAI, BDP 160 mcg BAI
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0208
	Comments
	Method	Log Rank
	Comments

8. Secondary Outcome

Title	Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Day 1 up to Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	91	90	92
>=1 adverse event	28 30.8%	32 35.6%	26 28.3%
>=1 severe TEAE	2 2.2%	0 0%	0 0%
>=1 treatment-related TEAE	1 1.1%	1 1.1%	2 2.2%
>=1 serious TEAE	1 1.1%	0 0%	0 0%
>=1 AE causing discontinuation	1 1.1%	0 0%	0 0%

9. Secondary Outcome

Title	Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
Description	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).
Time Frame	Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	91	90	92
>=1 abnormality	2 2.2%	2 2.2%	2 2.2%
Sitting systolic BP (low)	1 1.1%	1 1.1%	1 1.1%
Sitting diastolic BP (high)	1 1.1%	1 1.1%	1 1.1%

10. Secondary Outcome

Title	Participants With Findings During Oropharyngeal Examination During Treatment
Description	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.
Time Frame	Visits at weeks 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Placebo BAI	BDP 80 mcg BAI	BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.	40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.	80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
Measure Participants	91	90	92
>=1 evidence of oral candidiasis appearance	0 0%	0 0%	2 2.2%
Participants with a positive culture	0 0%	0 0%	1 1.1%

Adverse Events

Time Frame	Day 1 to Week 12
Arm/Group Title	Placebo BAI		BDP 80 mcg BAI		BDP 160 mcg BAI
Arm/Group Description	Placebo breath-actuated inhaler (BAI) twice daily.		40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.		80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.
All Cause Mortality
	Placebo BAI		BDP 80 mcg BAI		BDP 160 mcg BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		0/90 (0%)		0/92 (0%)
Serious Adverse Events
	Placebo BAI		BDP 80 mcg BAI		BDP 160 mcg BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/91 (1.1%)		0/90 (0%)		0/92 (0%)
Infections and infestations
Pneumonia	1/91 (1.1%)	1	0/90 (0%)	0	0/92 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	1/91 (1.1%)	1	0/90 (0%)	0	0/92 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo BAI		BDP 80 mcg BAI		BDP 160 mcg BAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/91 (0%)		0/90 (0%)		0/92 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.