Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications (NCT NCT01576718)

Last Updated: 2018-05-08

Results Overview

Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

889 participants

Primary outcome timeframe

Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Results posted on

2018-05-08

Participant Flow

1238 subjects with asthma at 180 centers were screened for enrollment. 889 subjects met entry criteria and were enrolled into the run-in period of the study. Of the 349 subjects who were not enrolled, 337 were excluded on the basis of inclusion/exclusion criteria, 5 subjects withdrew consent, and for 6 the reason given was "other".

Participant milestones

Participant milestones
Measure	Placebo MDPI (Run-In) Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).	Fp MDPI 50 mcg Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Pre-Assignment Period (Run-In Placebo) STARTED	889	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) COMPLETED	640	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) NOT COMPLETED	249	0	0	0	0	0	0
Treatment Period STARTED	0	107	107	106	107	106	107
Treatment Period Safety Population	0	107	107	106	107	106	106
Treatment Period Efficacy Population (Full Analysis Set)	0	107	106	102	107	105	103
Treatment Period COMPLETED	0	82	87	75	80	58	77
Treatment Period NOT COMPLETED	0	25	20	31	27	48	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo MDPI (Run-In) Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).	Fp MDPI 50 mcg Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Pre-Assignment Period (Run-In Placebo) Inclusion/exclusion criteria	49	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Withdrawal by Subject	17	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Randomization criteria not met	166	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Lost to Follow-up	2	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Other	15	0	0	0	0	0	0
Treatment Period Adverse Event	0	1	1	1	1	1	0
Treatment Period Withdrawal by Subject	0	1	1	0	2	4	2
Treatment Period Physician Decision	0	1	1	1	1	0	0
Treatment Period Protocol Violation	0	5	4	10	6	8	12
Treatment Period Sponsor request	0	1	0	0	0	1	0
Treatment Period Met stopping criteria	0	16	13	19	16	33	15
Treatment Period Lost to Follow-up	0	0	0	0	1	0	0
Treatment Period Noncompliance to study medication	0	0	0	0	0	1	1

Baseline Characteristics

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fp MDPI 50 mcg n=107 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=107 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=106 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=106 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=107 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Total n=640 Participants Total of all reporting groups
Age, Continuous	47.9 years STANDARD_DEVIATION 14.59 • n=5 Participants	48.7 years STANDARD_DEVIATION 12.48 • n=7 Participants	47.7 years STANDARD_DEVIATION 14.18 • n=5 Participants	50.9 years STANDARD_DEVIATION 13.32 • n=4 Participants	49.8 years STANDARD_DEVIATION 12.87 • n=21 Participants	49.2 years STANDARD_DEVIATION 13.26 • n=8 Participants	49.0 years STANDARD_DEVIATION 13.46 • n=8 Participants
Age, Customized Adolescents (12-17 years)	2 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	9 participants n=8 Participants
Age, Customized Adults (18-64 years)	94 participants n=5 Participants	99 participants n=7 Participants	90 participants n=5 Participants	90 participants n=4 Participants	94 participants n=21 Participants	96 participants n=8 Participants	563 participants n=8 Participants
Age, Customized Adults (65-84 years)	11 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants	16 participants n=4 Participants	11 participants n=21 Participants	10 participants n=8 Participants	68 participants n=8 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	55 Participants n=7 Participants	66 Participants n=5 Participants	72 Participants n=4 Participants	65 Participants n=21 Participants	58 Participants n=8 Participants	379 Participants n=8 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	52 Participants n=7 Participants	40 Participants n=5 Participants	35 Participants n=4 Participants	41 Participants n=21 Participants	49 Participants n=8 Participants	261 Participants n=8 Participants
Race/Ethnicity, Customized White	96 participants n=5 Participants	94 participants n=7 Participants	93 participants n=5 Participants	91 participants n=4 Participants	96 participants n=21 Participants	95 participants n=8 Participants	565 participants n=8 Participants
Race/Ethnicity, Customized Black	9 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	13 participants n=4 Participants	8 participants n=21 Participants	11 participants n=8 Participants	65 participants n=8 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	0 participants n=8 Participants	7 participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	12 participants n=4 Participants	6 participants n=21 Participants	9 participants n=8 Participants	47 participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	102 participants n=5 Participants	100 participants n=7 Participants	98 participants n=5 Participants	95 participants n=4 Participants	100 participants n=21 Participants	98 participants n=8 Participants	593 participants n=8 Participants
Weight	86.7 kg STANDARD_DEVIATION 23.73 • n=5 Participants	86.6 kg STANDARD_DEVIATION 22.90 • n=7 Participants	84.4 kg STANDARD_DEVIATION 21.89 • n=5 Participants	84.4 kg STANDARD_DEVIATION 20.56 • n=4 Participants	86.2 kg STANDARD_DEVIATION 25.19 • n=21 Participants	83.3 kg STANDARD_DEVIATION 16.76 • n=8 Participants	85.3 kg STANDARD_DEVIATION 21.95 • n=8 Participants
Height	169.4 cm STANDARD_DEVIATION 13.04 • n=5 Participants	168.7 cm STANDARD_DEVIATION 9.14 • n=7 Participants	168.4 cm STANDARD_DEVIATION 7.86 • n=5 Participants	167.4 cm STANDARD_DEVIATION 9.67 • n=4 Participants	168.1 cm STANDARD_DEVIATION 8.57 • n=21 Participants	168.0 cm STANDARD_DEVIATION 8.33 • n=8 Participants	168.3 cm STANDARD_DEVIATION 9.58 • n=8 Participants
Body Mass Index	31.3 kg/m^2 STANDARD_DEVIATION 17.88 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 7.60 • n=7 Participants	29.8 kg/m^2 STANDARD_DEVIATION 8.12 • n=5 Participants	30.1 kg/m^2 STANDARD_DEVIATION 6.81 • n=4 Participants	30.5 kg/m^2 STANDARD_DEVIATION 8.83 • n=21 Participants	29.6 kg/m^2 STANDARD_DEVIATION 6.03 • n=8 Participants	30.3 kg/m^2 STANDARD_DEVIATION 10.02 • n=8 Participants
Forced Expiratory Volume in 1 Second (FEV1)	2.108 liters STANDARD_DEVIATION 0.662 • n=5 Participants	2.031 liters STANDARD_DEVIATION 0.551 • n=7 Participants	1.999 liters STANDARD_DEVIATION 0.525 • n=5 Participants	2.016 liters STANDARD_DEVIATION 0.636 • n=4 Participants	1.984 liters STANDARD_DEVIATION 0.565 • n=21 Participants	1.955 liters STANDARD_DEVIATION 0.529 • n=8 Participants	2.016 liters STANDARD_DEVIATION 0.579 • n=8 Participants
% Predicted Expiratory Volume In 1 Second	63.7 percent predicted FEV1 STANDARD_DEVIATION 10.9 • n=5 Participants	63.1 percent predicted FEV1 STANDARD_DEVIATION 9.5 • n=7 Participants	63.4 percent predicted FEV1 STANDARD_DEVIATION 12.1 • n=5 Participants	65.3 percent predicted FEV1 STANDARD_DEVIATION 11.4 • n=4 Participants	63.1 percent predicted FEV1 STANDARD_DEVIATION 10.0 • n=21 Participants	62.5 percent predicted FEV1 STANDARD_DEVIATION 12.1 • n=8 Participants	63.5 percent predicted FEV1 STANDARD_DEVIATION 11.0 • n=8 Participants
Qualifying Airway Reversibility	31.6 percentage increase in FEV1 STANDARD_DEVIATION 22.4 • n=5 Participants	27.3 percentage increase in FEV1 STANDARD_DEVIATION 14.7 • n=7 Participants	30.4 percentage increase in FEV1 STANDARD_DEVIATION 25.2 • n=5 Participants	29.1 percentage increase in FEV1 STANDARD_DEVIATION 19.5 • n=4 Participants	28.9 percentage increase in FEV1 STANDARD_DEVIATION 19.1 • n=21 Participants	26.8 percentage increase in FEV1 STANDARD_DEVIATION 15.7 • n=8 Participants	29.0 percentage increase in FEV1 STANDARD_DEVIATION 19.8 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Population: Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; FEV1 data for Flovent Diskus is reported in outcome #12.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=104 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=102 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=97 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=103 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=98 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period	0.059 liters Standard Error 0.0269	0.101 liters Standard Error 0.0268	0.109 liters Standard Error 0.0278	0.125 liters Standard Error 0.0274	0.053 liters Standard Error 0.0283	—

SECONDARY outcome

Timeframe: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Population: Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; morning PEF data for Flovent Diskus is reported in outcome #13.

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=101 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=101 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=96 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=101 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=98 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period	10.48 liters/minute Standard Error 4.299	9.34 liters/minute Standard Error 4.245	10.03 liters/minute Standard Error 4.420	9.61 liters/minute Standard Error 4.307	2.24 liters/minute Standard Error 4.507	—

SECONDARY outcome

Timeframe: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Population: Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; evening PEF data for Flovent Diskus is reported in outcome #14.

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=103 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=99 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=96 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=102 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=96 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period	3.81 liters/minute Standard Error 4.183	6.41 liters/minute Standard Error 4.209	7.45 liters/minute Standard Error 4.335	10.97 liters/minute Standard Error 4.208	3.42 liters/minute Standard Error 4.462	—

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Full analysis set

The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma. Worsening asthma was defined as: 1. clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1. 2. any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced: * 3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1 * 3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used * 2 or more days in which the subject experienced a nighttime asthma symptom score of \>2 3. clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization. Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=107 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=106 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=102 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=105 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=103 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12	0.6872 probability Interval 0.5891 to 0.7665	0.6330 probability Interval 0.5307 to 0.7188	0.5852 probability Interval 0.4796 to 0.6766	0.6109 probability Interval 0.5093 to 0.6977	0.4722 probability Interval 0.3712 to 0.5665	0.5657 probability Interval 0.4617 to 0.6571

SECONDARY outcome

Timeframe: Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)

Population: Full analysis set including participants who contributed at least once to the analysis.

The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries. Data values are estimated means.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=96 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=90 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=91 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=99 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=93 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=95 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods	22.78 percentage of total 24 hour periods Standard Error 4.016	26.41 percentage of total 24 hour periods Standard Error 4.013	16.18 percentage of total 24 hour periods Standard Error 3.662	28.05 percentage of total 24 hour periods Standard Error 3.951	27.15 percentage of total 24 hour periods Standard Error 4.475	15.87 percentage of total 24 hour periods Standard Error 3.750

SECONDARY outcome

Timeframe: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

Population: Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=18 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=16 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=18 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=20 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=16 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)	117.6 pg*hr/mL Standard Deviation 145.79	126.8 pg*hr/mL Standard Deviation 33.73	292.0 pg*hr/mL Standard Deviation 162.28	462.8 pg*hr/mL Standard Deviation 262.45	—	162.3 pg*hr/mL Standard Deviation 74.79

SECONDARY outcome

Timeframe: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

Population: Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=18 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=16 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=18 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=20 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=16 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Maximum Observed Plasma Concentration (Cmax)	19.1 pg/mL Standard Deviation 15.53	26.5 pg/mL Standard Deviation 6.16	55.2 pg/mL Standard Deviation 29.12	83.0 pg/mL Standard Deviation 44.32	—	32.5 pg/mL Standard Deviation 13.92

SECONDARY outcome

Timeframe: Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

Population: Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=18 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=16 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=18 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=20 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=16 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Time Of Maximum Observed Plasma Concentration (Tmax)	1.0 hours Standard Deviation 0.54	1.2 hours Standard Deviation 1.85	2.2 hours Standard Deviation 3.58	1.4 hours Standard Deviation 2.60	—	1.8 hours Standard Deviation 2.75

SECONDARY outcome

Timeframe: Day 1 to Week 12

Population: Safety analysis set

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 AE which prevents normal daily activities. Relationship 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 the previously listed serious outcomes.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=107 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=107 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=106 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=106 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=106 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Any adverse event (AE)	31 participants	27 participants	34 participants	41 participants	33 participants	27 participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Severe AE	3 participants	1 participants	1 participants	1 participants	1 participants	0 participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Treatment-related AE	4 participants	1 participants	6 participants	9 participants	5 participants	2 participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Withdrawn from treatment due to AEs	1 participants	1 participants	1 participants	1 participants	1 participants	0 participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Deaths	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Other serious AEs	1 participants	1 participants	1 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12

Population: Safety analysis set

Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area. This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=107 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=107 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=106 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=106 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=106 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Patients With Positive Swab Test Results for Oral Candidiasis Screening	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Day 1	0 participants	0 participants	1 participants	0 participants	1 participants	1 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 1	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 2	0 participants	0 participants	1 participants	2 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 3	0 participants	0 participants	0 participants	4 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 4	1 participants	0 participants	1 participants	1 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 6	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 8	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 10	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Patients With Positive Swab Test Results for Oral Candidiasis Week 12	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 12, Endpoint

Population: Urine cortisol analysis set

24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=62 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=70 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=55 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=68 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=41 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=59 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint Baseline	65.3 nmol/day Standard Deviation 42.69	63.8 nmol/day Standard Deviation 44.70	66.6 nmol/day Standard Deviation 45.53	57.4 nmol/day Standard Deviation 34.68	74.3 nmol/day Standard Deviation 43.54	66.2 nmol/day Standard Deviation 42.68
24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint Week 12	71.8 nmol/day Standard Deviation 48.37	61.5 nmol/day Standard Deviation 45.73	66.8 nmol/day Standard Deviation 53.96	46.2 nmol/day Standard Deviation 38.67	69.2 nmol/day Standard Deviation 49.56	58.5 nmol/day Standard Deviation 43.75
24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint Endpoint	71.0 nmol/day Standard Deviation 48.31	61.5 nmol/day Standard Deviation 45.73	65.8 nmol/day Standard Deviation 53.33	45.0 nmol/day Standard Deviation 38.33	74.4 nmol/day Standard Deviation 54.97	58.4 nmol/day Standard Deviation 43.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model which includes data from all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=104 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=102 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=97 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=103 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=98 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=100 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)	0.063 liters Standard Error 0.027	0.102 liters Standard Error 0.0269	0.113 liters Standard Error 0.0279	0.129 liters Standard Error 0.0274	0.057 liters Standard Error 0.0284	0.110 liters Standard Error 0.0274

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=101 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=101 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=96 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=101 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=98 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=99 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)	10.85 liters/minute Standard Error 4.245	9.39 liters/minute Standard Error 4.193	10.29 liters/minute Standard Error 4.362	10.40 liters/minute Standard Error 4.254	2.52 liters/minute Standard Error 4.453	15.97 liters/minute Standard Error 4.283

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12

Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 50 mcg n=103 Participants Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=99 Participants Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=96 Participants Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=102 Participants Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=96 Participants Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Flovent Diskus 250mcg n=99 Participants Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)	4.22 liters/minute Standard Error 4.245	6.52 liters/minute Standard Error 4.275	7.89 liters/minute Standard Error 4.397	11.72 liters/minute Standard Error 4.271	3.35 liters/minute Standard Error 4.518	12.4 liters/minute Standard Error 4.309

Adverse Events

Flovent Diskus 250 mcg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Fp MDPI 100 mcg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Fp MDPI 200 mcg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Fp MDPI 400 mcg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Fp MDPI 50 mcg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo MDPI

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flovent Diskus 250 mcg n=106 participants at risk Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=107 participants at risk Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=106 participants at risk Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 participants at risk Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 50 mcg n=107 participants at risk Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=106 participants at risk Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Cardiac disorders Myocardial infarction	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.94% 1/106 • Number of events 1 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16
Infections and infestations Kidney infection	0.00% 0/106 • Day 1 to Week 16	0.93% 1/107 • Number of events 1 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.93% 1/107 • Number of events 1 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/106 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.00% 0/107 • Day 1 to Week 16	0.94% 1/106 • Number of events 1 • Day 1 to Week 16

Other adverse events

Other adverse events
Measure	Flovent Diskus 250 mcg n=106 participants at risk Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 100 mcg n=107 participants at risk Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 200 mcg n=106 participants at risk Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 400 mcg n=107 participants at risk Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Fp MDPI 50 mcg n=107 participants at risk Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.	Placebo MDPI n=106 participants at risk Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Nervous system disorders Headache	3.8% 4/106 • Number of events 4 • Day 1 to Week 16	3.7% 4/107 • Number of events 10 • Day 1 to Week 16	4.7% 5/106 • Number of events 6 • Day 1 to Week 16	6.5% 7/107 • Number of events 9 • Day 1 to Week 16	4.7% 5/107 • Number of events 5 • Day 1 to Week 16	5.7% 6/106 • Number of events 9 • Day 1 to Week 16

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER