A Safety and Efficacy Study of Beclomethasone Dipropionat... | NCT02031640

NCT02031640

ID	Type	Description	Link
2013-003397-27	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BDP 320 mcg BAI	Experimental	Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.	Drug: Beclomethasone dipropionate Drug: Placebo Drug: Albuterol/salbutamol
BDP 640 mcg BAI	Experimental	Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.	Drug: Beclomethasone dipropionate Drug: Placebo Drug: Albuterol/salbutamol
BDP 320 mcg MDI	Active Comparator	Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.	Drug: Beclomethasone dipropionate Drug: Placebo Drug: Albuterol/salbutamol
BDP 640 mcg MDI	Active Comparator	Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.	Drug: Beclomethasone dipropionate Drug: Placebo Drug: Albuterol/salbutamol
Placebo BAI and MDI	Placebo Comparator	Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.

Name	Type	Description	Arm Group Labels	Other Names
Beclomethasone dipropionate	Drug		BDP 320 mcg BAI BDP 320 mcg MDI BDP 640 mcg BAI BDP 640 mcg MDI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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) )	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).	Day 1 (baseline), Weeks 2, 4, 8, 12

Secondary Outcomes

Measure	Description	Time Frame
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)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severity of disease: The patient has persistent asthma, with a 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) (Hankinson et al 1999) reference values at screening visit.
Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 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 the screening visit
If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
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 pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
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 has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
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

Name	Affiliation	Role
Teva Medical Expert, MD	Teva Branded Pharmaceutical Products R&D, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 10851		Costa Mesa	California		United States
Teva Investigational Site 10849

PubMed Identifier	Type	Citation	Retractions
27510595	Derived	Amar NJ, Moss MH, Kerwin EM, Li J, Small CJ. Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma. Allergy Asthma Proc. 2016 Sep;37(5):359-69. doi: 10.2500/aap.2016.37.3983. Epub 2016 Aug 9.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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 throughout the treatment period.
BG001	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 throughout the treatment period.
BG002	BDP 640 mcg BAI	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.
BG003	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 throughout the treatment period.
BG004	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 throughout the treatment period.
BG005	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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) )

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).

Full analysis set- randomized patients with at least 1 dose of drug and 1 postbaseline trough am FEV1

Posted

Least Squares Mean

Standard Error

Liters

Day 1 (baseline), Weeks 2, 4, 8, 12

ID	Title	Description
OG000	Placebo BAI and MDI	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.
OG001	BDP 320 mcg BAI	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.
OG002	BDP 640 mcg BAI	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.
OG003	BDP 320 mcg MDI	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.
OG004	BDP 640 mcg MDI	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.

Units	Counts
Participants	OG000105 OG001104 OG002106 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.056± 0.0219 OG0010.09± 0.0221 OG0020.101± 0.0221 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.272		Least Square Mean (LSM) Difference	0.034			2-Sided	95	-0.027	0.095					Superiority
OG000 OG002		ANCOVA		0.1415

Secondary

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)

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.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

Liters/minute

Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12

ID	Title	Description
OG000	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 throughout the treatment period.

Secondary

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)

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.

Full Analysis Set

Posted

Least Squares Mean

Standard Error

Liters/minute

Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12

ID	Title	Description
OG000	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 throughout the treatment period.
OG001	BDP 320 mcg BAI

Secondary

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)

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.

Full analysis set

Posted

Least Squares Mean

Standard Error

number of inhalations

Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

ID	Title	Description
OG000	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 throughout the treatment period.
OG001	BDP 320 mcg BAI

Secondary

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)

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.

Full analysis set. Analysis used a MMRM with effects due to baseline score, sex, age, time, treatment, and time-by-treatment interaction.

Posted

Least Squares Mean

Standard Error

units on a scale

Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

ID	Title	Description
OG000	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 throughout the treatment period.

Secondary

Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma

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.

Full analysis set; unable to calculate as few patients met stopping criteria

Posted

Median

95% Confidence Interval

days

Day 1 - Week 12

ID	Title	Description
OG000	Placebo BAI or 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 throughout the treatment period.
OG001

Secondary

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

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.

Full analysis set

Posted

Count of Participants

Participants

Treatment period: Day 1 up to Week 12

ID	Title	Description
OG000	Placebo BAI or 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 throughout the treatment period.
OG001	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 throughout the treatment period.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	106	1	106	9	106
EG001	BAI 640 mcg/Day	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.	106	1	106	11	106
EG002	MDI 320 mcg/Day	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.	107	1	107	9	107
EG003	MDI 640 mcg/Day	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.	107	2	107	12	107
EG004	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.	106	0	106	2	106
EG005	Run-in Period Experience for Randomized Participants	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.	532	1	532	8	532

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0021 events1 affected107 at risk EG0030 events0 affected107 at risk EG0040 events0 affected106 at risk EG0050 events0 affected532 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Gastric disorder	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0021 events1 affected107 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0021 events1 affected107 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0021 events1 affected107 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected106 at risk EG0020 events0 affected107 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected106 at risk EG0020 events0 affected107 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013258	Steroids, Chlorinated
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines
D001337	Autonomic Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D018927	Anti-Asthmatic Agents
D019141	Respiratory System Agents
D045506	Therapeutic Uses

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Oral candidiasis	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0007 events5 affected106 at risk EG00112 events10 affected106 at risk EG0023 events3 affected107 at risk EG00311 events9 affected107 at risk EG0040 events0 affected106 at risk EG0057 events7 affected532 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment		EG0004 events4 affected106 at risk EG0011 events1 affected106 at risk EG0027 events7 affected107 at risk EG003

ID	Term
D001507	Beclomethasone
D000420	Albuterol
D001993	Bronchodilator Agents