Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Trough FEV1 |
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 µg and placebo, between indacaterol acetate 150 µg and placebo and indacaterol maleate and indacaterol acetate |
Day 14 of each of the three treatment periods |
|
Secondary |
Pharmacokinetics AUC 0-24hours at Steady State |
AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings |
Day 14 of each of the three treatment periods |
|
Secondary |
The Maximum Concentration (Cmax) at Steady State (ss) |
Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings. |
Day 14 of each of the three treatment periods |
|
Secondary |
Time of Maximal Plasma Concentration (Tmax) at Steady State |
Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14 |
Day 14 of each of the three treatment periods |
|
Secondary |
The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State |
The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided. |
Day 14 of each of the three treatment periods |
|
Secondary |
Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate |
Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate. |
Day 14 |
|
Secondary |
Time to Peak FEV1 on Day 14 |
The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo |
Day 14 of each of the three treatment periods |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints |
Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose |
Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints |
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days |
Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC) |
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function. |
Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted) |
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function. |
Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC |
Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation. |
Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75% |
The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days |
Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min |
|
Secondary |
Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC. |
Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 µg and placebo, and between indacaterol acetate 150 µg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h) |
Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods |
|
Secondary |
Rescue Medication Usage |
The mean daily number of puffs of rescue medication usage as reported by subjects via diary. |
14 days of treatment for each of the three treatment periods |
|
Secondary |
Mean Overall Peak Expiratory Flow (PEF) |
A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates |
Days 8 through Day 14 of each of the three treatment periods |
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