| Primary | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® | | OG003 | LAS100977 1.25 μg | Dry powder for inhalation administered via Genuair® | | OG004 | LAS100977 2.5 μg | Dry powder for inhalation administered via Genuair® | | OG005 | Salbutamol 400 μg | Pressurised inhalation suspension administered via Ventolin Evohaler® |
| | Units | Counts |
|---|
| Participants | - OG00059
- OG00160
- OG00260
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.202± 0.045
- OG0010.477± 0.045
- OG0020.524± 0.045
- OG003
|
|
| | 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 | Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate | <0.0001 | | Least Squares Mean DIfference | 0.405 | Standard Error of the Mean | 0.027 | 2-Sided | 95 | 0.353 | 0.458 | | | | | Superiority or Other | | | | |
|
| Secondary | Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Percent change | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Peak Forced Expiratory Volume in One Second (FEV1) | The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® | | OG003 |
|
| Secondary | Time to Peak Forced Expiratory Volume in One Second (FEV1) | The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Mean | Standard Deviation | Hours | | +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® | | OG003 |
|
| Secondary | Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1) | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +23 h and +24 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1 | FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® |
|
| Secondary | Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Percent change | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 |
|
| Secondary | Change From Baseline in Peak Forced Vital Capacity (FVC) | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | |
|
| Secondary | Peak Forced Vital Capacity (FVC) | The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | +15 min, +30 min, +1 h, +2 h, +3 h, +4 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® | | OG003 |
|
| Secondary | Time to Peak Forced Vital Capacity (FVC) | The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Mean | Standard Deviation | Hours | | +15 min, +30 min, +1 h, +2 h, +3 h, +4 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | Dry powder for inhalation administered via Genuair® | | OG003 |
|
| Secondary | Change From Baseline to Trough Forced Vital Capacity (FVC) | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +23 h +24 h post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC) | FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg | |
|
| Secondary | Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint | Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown. | Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period | Posted | | Least Squares Mean | Standard Error | Liters | | Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dry powder administered via the Genuair® inhaler or pressurised inhalation suspension administered via Ventolin Evohaler® | | OG001 | LAS100977 0.313 μg | Dry powder administered via the Genuair® inhaler | | OG002 | LAS100977 0.625 μg |
|