Dose B inhaled once daily for 6 weeks' treatment

Dose A inhaled once daily for 6 weeks' treatment

One placebo capsule taken each day on the last 7 days of the study

Prednisolone 10mg oral capsule taken each day on the last 7 days of the study

Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.

A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.

Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.

Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.

SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.

Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.

Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.

Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.