Study of Fluticasone Propionate Multidose Dry Powder Inha... | NCT02980133

ID	Type	Description	Link
2016-003835-39	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo MDPI	Placebo Comparator	Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.	Drug: Placebo MDPI
Fp MDPI 25 mcg BID	Experimental	Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.	Drug: Fluticasone Propionate
Fp MDPI 50 mcg BID	Experimental	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.	Drug: Fluticasone Propionate
FS MDPI 50/12.5 mcg BID	Experimental	Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.	Drug: Fluticasone Propionate/Salmeterol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluticasone Propionate	Drug	Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.	Fp MDPI 25 mcg BID Fp MDPI 50 mcg BID

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12	FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessments on Week 12 at the investigational center.	Baseline, Week 12
For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12	FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning percent predicted FEV1 measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning FEV1 values divided by the number of nonmissing assessments.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Morning PEF was determined in the morning, before administration of IMP or rescue medications. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH).
The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV).
The participant's persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Participants currently on a short-acting β2-agonist (SABA) only, regimen or as needed (PRN), are not eligible.
The participant has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol.
The participant (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device.
All participants must be able to replace their current SABA with albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) inhalation aerosol at the SV for use as needed for the duration of the study.
- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

The participant has a history of life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures.
The participant is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the participant's last study-related visit.
The participant has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the investigational medicinal product (IMP) or rescue medication formulation (that is, lactose).
The participant has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (for example, ketoconazole, ritonavir, clarithromycin) within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
The participant currently smokes or has a smoking history. The participant must not have used tobacco products within the past year (for example, cigarettes, cigars, chewing tobacco, or pipe tobacco).
The participant has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.
The participant has used immunosuppressive medications within 30 days before the SV.
The participant has untreated oral candidiasis at the SV. Participants with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.
The participant has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
The participant is an immediate relative of an employee of the clinical investigational center.
A member of the participant's household is participating in the study at the same time.
Vulnerable participants (that is, people kept in detention) are excluded from participation.
- Additional 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 13881		Birmingham	Alabama	35209	United States
Teva Investigational Site 13883

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo MDPI	Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.
FG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 micrograms (mcg) fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 5, 2018	Mar 5, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001211 ParticipantsBG002210 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001211 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001211 ParticipantsBG002

At-Home Baseline Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization.

Here, 'Number analyzed' signifies participants evaluable for this parameter.

Mean

Standard Deviation

percent predicted of FEV1

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001

In-Clinic Baseline Percent Predicted FEV1

FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center. 'Number of participants analyzed' for this parameter are 209, 211, 209, and 211 for each arm respectively.

Here, 'Number analyzed' signifies participants evaluable for this parameter.

Mean

Standard Deviation

percent predicted of FEV1

Title	Denominators	Categories
	ParticipantsBG000209 ParticipantsBG001

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

For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessments on Week 12 at the investigational center.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. Missing data was imputed using MNAR methodology for prematurely discontinue participants or MAR for completers with implausible data.

Posted

Least Squares Mean

Standard Error

percent predicted of FEV1

Baseline, Week 12

ID	Title	Description
OG000	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
OG001	Fp MDPI 50 mcg BID	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
OG002	FS MDPI 50/12.5 mcg BID	Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.

Units	Counts
Participants	OG000211 OG001209 OG002211

Title

Denominators

Categories

Title	Measurements
	OG00016.8± 1.32 OG00116.4± 1.32 OG00218.2± 1.29

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
OG001 OG002	Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.	ANCOVA		0.285	Threshold for significance at 0.05 level.	LS mean difference	1.9			2-Sided	95	-1.6	5.3					Superiority

Primary

For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning percent predicted FEV1 measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning FEV1 values divided by the number of nonmissing assessments.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. Missing data was imputed using missing not at random (MNAR) methodology for prematurely discontinue participants or missing at random (MAR) for completers with implausible data.

Posted

Least Squares Mean

Standard Error

percent predicted of FEV1

Baseline, Week 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID

Secondary

Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Morning PEF was determined in the morning, before administration of IMP or rescue medications. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

liters/minute

Baseline, Week 1 to 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID

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 Through 12

Participants recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each morning and evening in the electronic patient diary. An entry of 0 inhalations indicated no rescue medication was needed. To calculate the total daily use of albuterol/salbutamol inhalation aerosol (number of inhalations), the electronic patient diary entry on randomization visit (Baseline [Day 1]) was defined as the first day of analysis. The weekly average of the total daily inhalations was the average based on the available data for that week. The average was calculated as the sum of total daily inhalations over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and standard error (SE) were obtained using mixed model for repeated measures (MMRM).

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

inhalations

Baseline, Week 1 to 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.

Secondary

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12

Asthma symptom scores were recorded in the patient diary. Each participant assessed the symptoms of cough, wheeze, shortness of breath, and chest tightness and entered a single score that was inclusive of all symptoms. Daytime Symptom Score (determined in the evening) ranged from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. Nighttime Symptom Score (determined in the morning) ranged 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 was the average of the daytime and nighttime scores. The total daily asthma symptom score ranged from 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night. The weekly average was calculated as the sum of total daily asthma symptom scores over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and SE were obtained using MMRM.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 1 to 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID

Secondary

Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period

C-ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The first 4 items of the test were completed by the participant, while the last 3 items were completed by the participant's parents/legal guardians/caregivers. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranging from 0 to 27. These scores spanned the continuum of poor control of asthma (score ≤5) to complete control of asthma (score ≥25), with a cut off score of 19 indicating participants with poorly controlled asthma. LS mean and SE were obtained using MMRM.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 1 to 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
OG002	Fp MDPI 50 mcg BID

Secondary

Time to First Onset of Effect

The time to first onset of effect, defined as the first decrease from baseline in daily rescue medication use, was calculated based on the number of inhalations of rescue medication (albuterol/salbutamol hydrofluoroalkane metered-dose inhaler [HFA MDI] [90 mcg ex actuator] or equivalent) recorded by the participant each morning and evening in the patient diary built into the handheld device.

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

days

Baseline up to Week 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
OG002	Fp MDPI 50 mcg BID	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
OG003

Secondary

Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period

ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Posted

Number

percentage of participants

Baseline up to Week 12

ID	Title	Description
OG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
OG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
OG002	Fp MDPI 50 mcg BID	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
OG003	FS MDPI 50/12.5 mcg BID	Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.	209	1	209	11	209
EG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.	211	2	211	8	211
EG002	Fp MDPI 50 mcg BID	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.	208	1	208	11	208
EG003	FS MDPI 50/12.5 mcg BID	Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.	211	4	211	9	211

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected211 at risk EG0020 events0 affected208 at risk EG0031 events1 affected211 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected211 at risk EG0020 events0 affected208 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0011 events1 affected211 at risk EG0020 events0 affected208 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected209 at risk EG0010 events0 affected211 at risk EG0020 events0 affected208 at risk EG003
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected211 at risk EG0020 events0 affected208 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected211 at risk EG0020 events0 affected208 at risk EG003
Disruptive mood dysregulation disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected209 at risk EG0010 events0 affected211 at risk EG0021 events1 affected208 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected209 at risk EG0011 events1 affected211 at risk EG0020 events0 affected208 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
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D000068299	Salmeterol Xinafoate
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Placebo MDPI	Participants received matching placebo via MDPI for 12 weeks.
BG001	Fp MDPI 25 mcg BID	Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks.
BG002	Fp MDPI 50 mcg BID	Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks.
BG003	FS MDPI 50/12.5 mcg BID	Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
BG004	Total	Total of all reporting groups

ID	Term
D000068298	Fluticasone
D000068297	Fluticasone-Salmeterol Drug Combination