| Primary | Change From Baseline in Lung Clearance Index (LCI) | Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Mean | Standard Deviation | Days | | Baseline and Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.03± 1.28
- OG001-0.16± 1.15
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.130 | | Mean Difference (Net) | 0.28 | Standard Deviation | 0.31 | 2-Sided | 90 | -0.24 | 0.79 | | | | | Superiority | | |
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| Secondary | Change From Baseline in FEV1 Pre-bronchodilator | Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |
| Secondary | Change From Baseline in FEV1 Post-bronchodilator | Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |
| Secondary | Change From Baseline in FVC Pre Bronchodilator | Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Least Squares Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |
| Secondary | Change From Baseline in FVC Post- Bronchodilator | Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Least Squares Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |
| Secondary | Change From Baseline in TLC | Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data. | Posted | | Least Squares Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |
| Secondary | Change From Baseline in RV | Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data | Posted | | Least Squares Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
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| Secondary | Change From Baseline in FRC | Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data | Posted | | Least Squares Mean | Standard Deviation | Liters | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
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| Secondary | Change From Baseline in DLCO | Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood. | Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data | Posted | | Least Squares Mean | Standard Error | ml/min/mmHg | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
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| Secondary | Plasma Concentration of QBW251 by TMax (0-8hours) | Tmax is the time to reach the maximum concentration after drug administration. | Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28 | Posted | | Median | Full Range | hr | | Day 1, Day 28 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) |
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| Secondary | Plasma Concentration of QBW251 by CMax (0-8hours) | Cmax is the observed maximum plasma concentration following drug administration. | Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28 | Posted | | Mean | Standard Deviation | ng/mL | | Day 1, Day 28 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) |
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| Secondary | Plasma Concentration of QBW251 by AUClast (0-8hours) | AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. | Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28 | Posted | | Mean | Standard Deviation | hr×ng/mL | | Day 1, Day 28 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) |
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| Secondary | Plasma Concentration of QBW251 by AUC0-12h | AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours. | PK analysis set: included all patients with at least one available valid PK concentration measurement. Due to practicalities of study conduct PK samples were collected only up to 8 hours. As a result, from noncompartmental analysis AUClast was not calculated up to 12 hours after dosing So this data is not available. | Posted | | | | | | Day 1, Day 28 | | | | ID | Title | Description |
|---|
| OG000 | QBW251 | QBW251(28 day treatment period) and placebo (42 days, run-in and wash-out periods) | | OG001 | Placebo | Placebo (70 days, run-in, treatment and wash-out periods) |
| |