Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids (NCT NCT01479621)

Last Updated: 2017-06-05

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

909 participants

Primary outcome timeframe

Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

Results posted on

2017-06-05

Participant Flow

A total of 1903 subjects with asthma were screened for enrollment into this study. Of the 994 subjects who were not enrolled, 983 were excluded on the basis of inclusion/exclusion criteria and 6 subjects withdrew consent, and for 5 the reason given was "other".

909 subjects at 188 centers met entry criteria and were considered to be eligible for enrollment into the run-in period of the study.

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 12.5 mcg Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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 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.	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 100mcg 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 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	909	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) COMPLETED	622	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) NOT COMPLETED	287	0	0	0	0	0	0
Treatment Period STARTED	0	103	104	104	103	104	104
Treatment Period Safety Population	0	103	104	104	103	104	104
Treatment Period Full Analysis Set	0	102	101	102	102	102	102
Treatment Period COMPLETED	0	79	83	92	82	63	84
Treatment Period NOT COMPLETED	0	24	21	12	21	41	20

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 12.5 mcg Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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 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.	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 100mcg 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 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	93	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Withdrawal by Subject	19	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Randomization criteria not met	153	0	0	0	0	0	0
Pre-Assignment Period (Run-In Placebo) Lost to Follow-up	7	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	0	0	0	1	2	2
Treatment Period Withdrawal by Subject	0	4	2	2	5	5	1
Treatment Period Physician Decision	0	0	0	0	1	1	0
Treatment Period Non-compliance to study drug	0	1	0	0	0	0	1
Treatment Period Protocol Violation	0	9	6	5	2	10	6
Treatment Period Pregnancy	0	0	2	0	0	0	0
Treatment Period Sponsor request subject to be withdrawn	0	2	3	1	1	1	3
Treatment Period Lost to Follow-up	0	0	1	0	2	2	1
Treatment Period Met stopping criteria	0	8	7	4	9	20	6

Baseline Characteristics

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fp MDPI 12.5 mcg n=103 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=104 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=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=103 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.	Placebo MDPI n=104 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 100mcg n=104 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 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=622 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 16.94 • n=5 Participants	42.4 years STANDARD_DEVIATION 16.02 • n=7 Participants	39.1 years STANDARD_DEVIATION 16.06 • n=5 Participants	36.9 years STANDARD_DEVIATION 15.34 • n=4 Participants	39.7 years STANDARD_DEVIATION 15.28 • n=21 Participants	40.0 years STANDARD_DEVIATION 15.34 • n=8 Participants	39.9 years STANDARD_DEVIATION 15.87 • n=8 Participants
Age, Customized 12-17 years	10 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	52 Participants n=8 Participants
Age, Customized Adults (18-64 years)	85 Participants n=5 Participants	90 Participants n=7 Participants	86 Participants n=5 Participants	88 Participants n=4 Participants	93 Participants n=21 Participants	93 Participants n=8 Participants	535 Participants n=8 Participants
Age, Customized Adults (65+ years)	8 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=8 Participants	35 Participants n=8 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	63 Participants n=7 Participants	60 Participants n=5 Participants	60 Participants n=4 Participants	55 Participants n=21 Participants	63 Participants n=8 Participants	358 Participants n=8 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	41 Participants n=7 Participants	44 Participants n=5 Participants	43 Participants n=4 Participants	49 Participants n=21 Participants	41 Participants n=8 Participants	264 Participants n=8 Participants
Race/Ethnicity, Customized White	91 Participants n=5 Participants	91 Participants n=7 Participants	90 Participants n=5 Participants	85 Participants n=4 Participants	85 Participants n=21 Participants	85 Participants n=8 Participants	527 Participants n=8 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	17 Participants n=21 Participants	17 Participants n=8 Participants	81 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Weight	82.0 kg STANDARD_DEVIATION 23.29 • n=5 Participants	80.4 kg STANDARD_DEVIATION 19.62 • n=7 Participants	78.7 kg STANDARD_DEVIATION 23.08 • n=5 Participants	84.6 kg STANDARD_DEVIATION 23.51 • n=4 Participants	80.5 kg STANDARD_DEVIATION 20.00 • n=21 Participants	81.5 kg STANDARD_DEVIATION 23.53 • n=8 Participants	81.3 kg STANDARD_DEVIATION 22.22 • n=8 Participants
Race/Ethnicity, Customized Other	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 Hispanic or Latino	9 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	6 Participants n=8 Participants	50 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	94 Participants n=5 Participants	100 Participants n=7 Participants	97 Participants n=5 Participants	90 Participants n=4 Participants	93 Participants n=21 Participants	98 Participants n=8 Participants	572 Participants n=8 Participants
Height	168.8 cm STANDARD_DEVIATION 10.54 • n=5 Participants	169.2 cm STANDARD_DEVIATION 8.89 • n=7 Participants	168.6 cm STANDARD_DEVIATION 10.33 • n=5 Participants	168.7 cm STANDARD_DEVIATION 10.94 • n=4 Participants	169.5 cm STANDARD_DEVIATION 9.25 • n=21 Participants	169.0 cm STANDARD_DEVIATION 9.39 • n=8 Participants	169.0 cm STANDARD_DEVIATION 9.88 • n=8 Participants
Body Mass Index	28.7 kg/m^2 STANDARD_DEVIATION 7.43 • n=5 Participants	28.1 kg/m^2 STANDARD_DEVIATION 6.47 • n=7 Participants	27.5 kg/m^2 STANDARD_DEVIATION 6.78 • n=5 Participants	29.6 kg/m^2 STANDARD_DEVIATION 7.54 • n=4 Participants	28.0 kg/m^2 STANDARD_DEVIATION 6.61 • n=21 Participants	28.4 kg/m^2 STANDARD_DEVIATION 7.31 • n=8 Participants	28.4 kg/m^2 STANDARD_DEVIATION 7.04 • n=8 Participants
Forced Expiratory Volume in 1 Second (FEV1)	2.3 liters STANDARD_DEVIATION 0.69 • n=5 Participants	2.2 liters STANDARD_DEVIATION 0.59 • n=7 Participants	2.2 liters STANDARD_DEVIATION 0.63 • n=5 Participants	2.3 liters STANDARD_DEVIATION 0.66 • n=4 Participants	2.3 liters STANDARD_DEVIATION 0.62 • n=21 Participants	2.2 liters STANDARD_DEVIATION 0.66 • n=8 Participants	2.2 liters STANDARD_DEVIATION 0.64 • n=8 Participants
% Predicted Expiratory Volume In 1 Second	66.6 percent predicted FEV1 STANDARD_DEVIATION 11.80 • n=5 Participants	67.5 percent predicted FEV1 STANDARD_DEVIATION 10.50 • n=7 Participants	66.3 percent predicted FEV1 STANDARD_DEVIATION 11.15 • n=5 Participants	66.4 percent predicted FEV1 STANDARD_DEVIATION 11.61 • n=4 Participants	66.4 percent predicted FEV1 STANDARD_DEVIATION 11.14 • n=21 Participants	65.3 percent predicted FEV1 STANDARD_DEVIATION 11.74 • n=8 Participants	66.4 percent predicted FEV1 STANDARD_DEVIATION 11.30 • n=8 Participants
Qualifying Airway Reversibility	26.7 percentage increase in FEV1 STANDARD_DEVIATION 12.01 • n=5 Participants	26.0 percentage increase in FEV1 STANDARD_DEVIATION 11.86 • n=7 Participants	24.3 percentage increase in FEV1 STANDARD_DEVIATION 10.63 • n=5 Participants	27.6 percentage increase in FEV1 STANDARD_DEVIATION 12.92 • n=4 Participants	30.6 percentage increase in FEV1 STANDARD_DEVIATION 17.84 • n=21 Participants	26.2 percentage increase in FEV1 STANDARD_DEVIATION 12.50 • n=8 Participants	26.9 percentage increase in FEV1 STANDARD_DEVIATION 13.25 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

Population: Full analysis set, (participants who contributed \>=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #11).

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=94 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=97 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=100 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=94 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.	Placebo MDPI n=94 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 100mcg 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 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	0.170 liters Standard Error 0.0300	0.229 liters Standard Error 0.0295	0.243 liters Standard Error 0.0288	0.267 liters Standard Error 0.0300	0.118 liters Standard Error 0.0302	—

SECONDARY outcome

Timeframe: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

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 12.5 mcg n=94 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=97 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=99 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=94 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.	Placebo MDPI n=92 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 100mcg 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 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	30.99 liters/minute Standard Error 4.600	21.01 liters/minute Standard Error 4.521	29.58 liters/minute Standard Error 4.396	27.55 liters/minute Standard Error 4.610	9.26 liters/minute Standard Error 4.755	—

SECONDARY outcome

Timeframe: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

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 12.5 mcg n=92 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=98 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=99 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=92 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.	Placebo MDPI n=92 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 100mcg 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 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 Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period	27.65 liters/minute Standard Error 4.474	18.69 liters/minute Standard Error 4.347	22.20 liters/minute Standard Error 4.237	20.48 liters/minute Standard Error 4.490	9.42 liters/minute Standard Error 4.588	—

SECONDARY outcome

Timeframe: Baseline (Days -7 to -1), During Study (Days 1-84)

Population: Full analysis set

The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device. Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=102 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=101 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=102 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.	Placebo MDPI n=102 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 100mcg 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 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 During the 12-Week Treatment Period	34.08 percentage of total 24 hour periods Standard Error 3.909	31.76 percentage of total 24 hour periods Standard Error 4.229	28.06 percentage of total 24 hour periods Standard Error 3.799	24.07 percentage of total 24 hour periods Standard Error 4.283	21.30 percentage of total 24 hour periods Standard Error 4.668	29.82 percentage of total 24 hour periods Standard Error 4.191

SECONDARY outcome

Timeframe: Day 1 to Day 84

Population: Full analysis set

The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=102 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=101 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=102 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.	Placebo MDPI n=102 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 100mcg 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 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.
Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12	0.8041 probability Interval 0.7067 to 0.872	0.7895 probability Interval 0.6927 to 0.8589	0.9077 probability Interval 0.83 to 0.9509	0.7657 probability Interval 0.666 to 0.8392	0.5655 probability Interval 0.4528 to 0.6636	0.8272 probability Interval 0.7332 to 0.8905

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: Pharmacokinetics analysis set. Placebo samples not included in these results.

Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=16 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=22 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=19 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=17 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.	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 100mcg n=21 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 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 Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp	21.6 pg*hr/mL Standard Deviation 27.09	42.0 pg*hr/mL Standard Deviation 23.21	63.2 pg*hr/mL Standard Deviation 22.64	153.8 pg*hr/mL Standard Deviation 91.42	—	10.4 pg*hr/mL Standard Deviation 45.65

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: Pharmacokinetics analysis set. Placebo samples not included in these results.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=16 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=22 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=19 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=17 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.	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 100mcg n=21 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 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) of Fp	5.4 pg/mL Standard Deviation 4.23	10.0 pg/mL Standard Deviation 5.35	12.9 pg/mL Standard Deviation 5.13	33.6 pg/mL Standard Deviation 15.49	—	23.4 pg/mL Standard Deviation 10.73

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: Pharmacokinetics analysis set. Placebo samples not included in these results.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=16 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=22 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=19 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=17 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.	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 100mcg n=21 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 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 Concentration (Tmax) of Fp	1.2 hours Standard Deviation 0.97	1.4 hours Standard Deviation 2.43	1.7 hours Standard Deviation 2.55	1.1 hours Standard Deviation 0.95	—	1.7 hours Standard Deviation 2.61

SECONDARY outcome

Timeframe: Day 1 -84

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 12.5 mcg n=103 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=104 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=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=103 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.	Placebo MDPI n=104 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 100mcg n=104 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 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 Withdrawn from treatment due to AE	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Any adverse event (AE)	31 Participants	32 Participants	36 Participants	37 Participants	31 Participants	32 Participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Severe AE	0 Participants	0 Participants	3 Participants	2 Participants	3 Participants	3 Participants
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Treatment-related AE	6 Participants	3 Participants	3 Participants	2 Participants	1 Participants	1 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 AE	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12

Population: Safety population

Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. 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. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study. Data format: Time frame, \<signs of oral candidiasis?\> yes or no

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=103 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=104 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=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=103 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.	Placebo MDPI n=104 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 100mcg n=104 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 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.
Oropharyngeal Exam Findings at Each Study Visit Screening - No	103 Participants	104 Participants	104 Participants	103 Participants	104 Participants	104 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 0 - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 0 - No	103 Participants	104 Participants	104 Participants	103 Participants	104 Participants	104 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 1 - No	93 Participants	98 Participants	100 Participants	100 Participants	94 Participants	98 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 2 - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 12 - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 12 - No	102 Participants	102 Participants	103 Participants	100 Participants	97 Participants	101 Participants
Oropharyngeal Exam Findings at Each Study Visit Screening - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 1 - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 2 - No	90 Participants	93 Participants	99 Participants	95 Participants	83 Participants	93 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 4 - Yes (positive culture)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 4 - No	88 Participants	89 Participants	97 Participants	91 Participants	75 Participants	90 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 8 - Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Oropharyngeal Exam Findings at Each Study Visit Week 8 - No	84 Participants	85 Participants	92 Participants	84 Participants	66 Participants	83 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

Population: Full analysis set, (participants who contributed \>=1 to the analysis). Data from one site omitted due to GCP concerns.

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 including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=94 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=97 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=100 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=94 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.	Placebo MDPI n=94 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 100mcg n=96 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 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 Inclusive of Flovent Diskus Data	0.172 liters Standard Error 0.0293	0.232 liters Standard Error 0.0288	0.245 liters Standard Error 0.0280	0.268 liters Standard Error 0.0292	0.120 liters Standard Error 0.0294	0.234 liters Standard Error 0.0288

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

Population: Full analysis set, (participants who contributed \>=1 to the analysis). Data from one site omitted due to GCP concerns.

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 including 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 12.5 mcg n=94 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=97 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=99 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=94 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.	Placebo MDPI n=92 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 100mcg n=96 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 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 Inclusive of Flovent Diskus Data	31.20 liters/minute Standard Error 4.544	21.27 liters/minute Standard Error 4.465	29.63 liters/minute Standard Error 4.339	27.66 liters/minute Standard Error 4.550	9.30 liters/minute Standard Error 4.700	26.96 liters/minute Standard Error 4.496

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

Population: Full analysis set, (participants who contributed \>=1 to the analysis). Data from one site omitted due to GCP concerns.

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 including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

Outcome measures

Outcome measures
Measure	Fp MDPI 12.5 mcg n=92 Participants Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 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 25 mcg n=98 Participants Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 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=99 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=92 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.	Placebo MDPI n=92 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 100mcg n=95 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 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 Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data	28.00 liters/minute Standard Error 4.442	18.97 liters/minute Standard Error 4.315	22.27 liters/minute Standard Error 4.206	20.47 liters/minute Standard Error 4.453	9.70 liters/minute Standard Error 4.557	24.95 liters/minute Standard Error 4.356

Adverse Events

Flovent Diskus 100mcg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Fp MDPI 100 mcg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Fp MDPI 12.5 mcg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Fp MDPI 25 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: 10 other events

Deaths: 0 deaths

Placebo MDPI

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Flovent Diskus 100mcg n=104 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 an open-label manner.	Fp MDPI 100 mcg n=103 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.	Fp MDPI 12.5 mcg n=103 participants at risk Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.	Fp MDPI 25 mcg n=104 participants at risk Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.	Fp MDPI 50 mcg n=104 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.	Placebo MDPI n=104 participants at risk Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
Blood and lymphatic system disorders Anaemia	0.00% 0/104 • Day 1 to 84	0.97% 1/103 • Number of events 1 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84
Immune system disorders Anaphylactic shock	0.96% 1/104 • Number of events 1 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84
Infections and infestations Groin abscess	0.96% 1/104 • Number of events 1 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/104 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.96% 1/104 • Number of events 1 • Day 1 to 84
Nervous system disorders Migraine	0.00% 0/104 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.96% 1/104 • Number of events 1 • Day 1 to 84	0.00% 0/104 • Day 1 to 84
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/104 • Day 1 to 84	0.97% 1/103 • Number of events 1 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/104 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.96% 1/104 • Number of events 1 • Day 1 to 84
Vascular disorders Hypertension	0.00% 0/104 • Day 1 to 84	0.97% 1/103 • Number of events 1 • Day 1 to 84	0.00% 0/103 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84	0.00% 0/104 • Day 1 to 84

Other adverse events

Other adverse events
Measure	Flovent Diskus 100mcg n=104 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 an open-label manner.	Fp MDPI 100 mcg n=103 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.	Fp MDPI 12.5 mcg n=103 participants at risk Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.	Fp MDPI 25 mcg n=104 participants at risk Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.	Fp MDPI 50 mcg n=104 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.	Placebo MDPI n=104 participants at risk Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
Infections and infestations Nasopharyngitis	0.96% 1/104 • Number of events 3 • Day 1 to 84	2.9% 3/103 • Number of events 3 • Day 1 to 84	3.9% 4/103 • Number of events 4 • Day 1 to 84	4.8% 5/104 • Number of events 5 • Day 1 to 84	6.7% 7/104 • Number of events 7 • Day 1 to 84	4.8% 5/104 • Number of events 5 • Day 1 to 84
Infections and infestations Upper respiratory tract infection	3.8% 4/104 • Number of events 4 • Day 1 to 84	4.9% 5/103 • Number of events 5 • Day 1 to 84	6.8% 7/103 • Number of events 7 • Day 1 to 84	1.9% 2/104 • Number of events 2 • Day 1 to 84	2.9% 3/104 • Number of events 3 • Day 1 to 84	2.9% 3/104 • Number of events 3 • Day 1 to 84

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 1-215-591-3000

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