Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD
Brief summary
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
Interventions
DRUGLAS100977
Dry powder inhalation,Once daily, single dose
DRUGReference
Dry powder inhalation (capsule),single dose
DRUGPlacebo
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and non-pregnant, non-lactating females aged 40 or older. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction. 3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value 4. Post-salbutamol FEV1/FVC \< 70% at screening visit. 5. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation. 6. Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years. 7. Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
Exclusion criteria
1. History or current diagnosis of asthma. 2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit. 3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit. 4. Clinically significant respiratory conditions other than COPD condition. 5. Clinically significant cardiovascular conditions. 6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry. 7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation. 8. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | Day 2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Day 1 | 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 |
| Absolute Forced Expiratory Volume in One Second (FEV1) Values | Up to Day 2 | 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 |
| Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | Day 1 | 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 |
| Time to Peak Forced Expiratory Volume in One Second (FEV1) | 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 |
| Change From Baseline in Trough Forced Vital Capacity (FVC) | Day 2 | 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 |
| Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Day 1 | 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 |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Up to Day 2 | 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 |
| Absolute Forced Vital Capacity (FVC) Values | Up to Day 2 | 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 |
| Change From Baseline in Peak Forced Vital Capacity (FVC) | Day 1 | 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 |
| Time to Peak Forced Vital Capacity (FVC) | 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 |
| Change From Baseline in Inspiratory Capacity (IC) | Up to Day 2 | 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 |
| Absolute Inspiratory Capacity (IC) Values | Up to Day 2 | 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 |
| Change From Baseline in Forced Vital Capacity (FVC) | Up to Day 2 | 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 |
Countries
Germany
Participant flow
Recruitment details
The study was conducted in 9 sites in Germany, 8 of which randomized patients
Pre-assignment details
Screening took place 14±2 days before randomization. After screening, eligible patients entered a run-in period to assess clinical stability. A total of 87 patients were screened, of whom 70 patients were assessed as eligible and randomized; 17 were not randomized due to screening failure (primarily non-fulfillment of inclusion/exclusion criteria)
Participants by arm
| Arm | Count |
|---|---|
| Overall Population All patients who were randomized and received at least one dose of investigational medicinal product | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Stability criteria not fulfilled | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2 | Stability criteria not fulfilled | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 3 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 4 | Adverse Event | 1 | 0 | 1 | 0 | 0 | 0 |
| Period 5 | Stability criteria not fulfilled | 0 | 0 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 68 | 4 / 67 | 1 / 66 | 1 / 66 | 2 / 67 | 5 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 67 | 0 / 66 | 1 / 66 | 1 / 67 | 0 / 68 |
Outcome results
Primary
Change From Baseline in 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
Time frame: Day 2
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | -0.035 Liters | Standard Error 0.024 |
| LAS100977 0.625 μg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.066 Liters | Standard Error 0.024 |
| LAS100977 2.5 μg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.168 Liters | Standard Error 0.024 |
| LAS100977 5 μg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.198 Liters | Standard Error 0.024 |
| LAS100977 10 μg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.223 Liters | Standard Error 0.024 |
| Indacaterol 150 μg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) | 0.076 Liters | Standard Error 0.024 |
p-value: <0.000195% CI: [0.219, 0.298]ANCOVA
p-value: <0.000195% CI: [0.194, 0.273]ANCOVA
p-value: <0.000195% CI: [0.164, 0.242]ANCOVA
p-value: <0.000195% CI: [0.062, 0.141]ANCOVA
Secondary
Absolute Forced Expiratory Volume in One Second (FEV1) Values
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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.428 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.494 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.464 Liters | Standard Error 0.062 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.494 Liters | Standard Error 0.06 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.409 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.411 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.485 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.491 Liters | Standard Error 0.061 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.490 Liters | Standard Error 0.062 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.475 Liters | Standard Error 0.059 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.464 Liters | Standard Error 0.064 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.474 Liters | Standard Error 0.06 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.482 Liters | Standard Error 0.059 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.477 Liters | Standard Error 0.062 |
| Placebo | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.477 Liters | Standard Error 0.061 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.605 Liters | Standard Error 0.068 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.721 Liters | Standard Error 0.07 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.674 Liters | Standard Error 0.07 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.592 Liters | Standard Error 0.064 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.506 Liters | Standard Error 0.065 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.599 Liters | Standard Error 0.07 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.640 Liters | Standard Error 0.064 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.542 Liters | Standard Error 0.068 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.657 Liters | Standard Error 0.066 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.564 Liters | Standard Error 0.068 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.671 Liters | Standard Error 0.067 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.707 Liters | Standard Error 0.069 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.549 Liters | Standard Error 0.064 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.629 Liters | Standard Error 0.069 |
| LAS100977 0.625 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.730 Liters | Standard Error 0.068 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.627 Liters | Standard Error 0.063 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.660 Liters | Standard Error 0.066 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.701 Liters | Standard Error 0.067 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.655 Liters | Standard Error 0.071 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.472 Liters | Standard Error 0.062 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.561 Liters | Standard Error 0.064 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.748 Liters | Standard Error 0.07 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.606 Liters | Standard Error 0.07 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.780 Liters | Standard Error 0.068 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.575 Liters | Standard Error 0.068 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.758 Liters | Standard Error 0.068 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.688 Liters | Standard Error 0.065 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.732 Liters | Standard Error 0.07 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.658 Liters | Standard Error 0.063 |
| LAS100977 2.5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.646 Liters | Standard Error 0.068 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.790 Liters | Standard Error 0.07 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.483 Liters | Standard Error 0.063 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.568 Liters | Standard Error 0.062 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.644 Liters | Standard Error 0.064 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.685 Liters | Standard Error 0.065 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.701 Liters | Standard Error 0.067 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.729 Liters | Standard Error 0.067 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.758 Liters | Standard Error 0.069 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.759 Liters | Standard Error 0.069 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.746 Liters | Standard Error 0.07 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.686 Liters | Standard Error 0.068 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.693 Liters | Standard Error 0.069 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.649 Liters | Standard Error 0.07 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.688 Liters | Standard Error 0.07 |
| LAS100977 5 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.566 Liters | Standard Error 0.069 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.814 Liters | Standard Error 0.071 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.701 Liters | Standard Error 0.074 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.493 Liters | Standard Error 0.065 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.740 Liters | Standard Error 0.072 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.673 Liters | Standard Error 0.066 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.761 Liters | Standard Error 0.073 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.607 Liters | Standard Error 0.069 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.726 Liters | Standard Error 0.073 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.733 Liters | Standard Error 0.069 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.754 Liters | Standard Error 0.068 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.804 Liters | Standard Error 0.074 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.708 Liters | Standard Error 0.067 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.610 Liters | Standard Error 0.065 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.806 Liters | Standard Error 0.073 |
| LAS100977 10 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.840 Liters | Standard Error 0.073 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 8 hr | 1.612 Liters | Standard Error 0.065 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 3 hr | 1.672 Liters | Standard Error 0.066 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Baseline | 1.488 Liters | Standard Error 0.064 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 12 hr | 1.565 Liters | Standard Error 0.067 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 2 hr | 1.642 Liters | Standard Error 0.066 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 1 hr | 1.624 Liters | Standard Error 0.061 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 14 hr | 1.585 Liters | Standard Error 0.065 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.5 hr | 1.683 Liters | Standard Error 0.065 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 36 hr | 1.524 Liters | Standard Error 0.064 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 23 hr | 1.538 Liters | Standard Error 0.064 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.25 hr | 1.620 Liters | Standard Error 0.063 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 0.08 hr | 1.585 Liters | Standard Error 0.064 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 2 24 hr | 1.576 Liters | Standard Error 0.066 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 6 hr | 1.623 Liters | Standard Error 0.065 |
| Indacaterol 150 μg | Absolute Forced Expiratory Volume in One Second (FEV1) Values | Day 1 4 hr | 1.677 Liters | Standard Error 0.067 |
Secondary
Absolute Forced Vital Capacity (FVC) Values
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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.169 Liters | Standard Error 0.098 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.217 Liters | Standard Error 0.104 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.185 Liters | Standard Error 0.099 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.201 Liters | Standard Error 0.101 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.130 Liters | Standard Error 0.105 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.095 Liters | Standard Error 0.103 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.055 Liters | Standard Error 0.107 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.145 Liters | Standard Error 0.102 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.232 Liters | Standard Error 0.103 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.165 Liters | Standard Error 0.101 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.075 Liters | Standard Error 0.108 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.205 Liters | Standard Error 0.106 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.220 Liters | Standard Error 0.097 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.292 Liters | Standard Error 0.126 |
| Placebo | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.181 Liters | Standard Error 0.101 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.195 Liters | Standard Error 0.104 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.233 Liters | Standard Error 0.111 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.436 Liters | Standard Error 0.11 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.289 Liters | Standard Error 0.109 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.406 Liters | Standard Error 0.118 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.443 Liters | Standard Error 0.109 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.458 Liters | Standard Error 0.114 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.302 Liters | Standard Error 0.112 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.418 Liters | Standard Error 0.111 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.492 Liters | Standard Error 0.108 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.535 Liters | Standard Error 0.118 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.335 Liters | Standard Error 0.109 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.284 Liters | Standard Error 0.109 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.399 Liters | Standard Error 0.11 |
| LAS100977 0.625 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.293 Liters | Standard Error 0.112 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.329 Liters | Standard Error 0.102 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.290 Liters | Standard Error 0.107 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.251 Liters | Standard Error 0.108 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.396 Liters | Standard Error 0.108 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.516 Liters | Standard Error 0.103 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.137 Liters | Standard Error 0.102 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.359 Liters | Standard Error 0.111 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.464 Liters | Standard Error 0.109 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.318 Liters | Standard Error 0.105 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.400 Liters | Standard Error 0.107 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.368 Liters | Standard Error 0.105 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.406 Liters | Standard Error 0.107 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.475 Liters | Standard Error 0.106 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.323 Liters | Standard Error 0.104 |
| LAS100977 2.5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.445 Liters | Standard Error 0.11 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.478 Liters | Standard Error 0.099 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.411 Liters | Standard Error 0.107 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.341 Liters | Standard Error 0.107 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.360 Liters | Standard Error 0.102 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.212 Liters | Standard Error 0.102 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.153 Liters | Standard Error 0.094 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.331 Liters | Standard Error 0.1 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.365 Liters | Standard Error 0.1 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.417 Liters | Standard Error 0.101 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.394 Liters | Standard Error 0.102 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.454 Liters | Standard Error 0.102 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.478 Liters | Standard Error 0.103 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.501 Liters | Standard Error 0.109 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.488 Liters | Standard Error 0.107 |
| LAS100977 5 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.425 Liters | Standard Error 0.105 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.534 Liters | Standard Error 0.119 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.345 Liters | Standard Error 0.11 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.608 Liters | Standard Error 0.114 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.447 Liters | Standard Error 0.11 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.520 Liters | Standard Error 0.118 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.636 Liters | Standard Error 0.122 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.488 Liters | Standard Error 0.112 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.479 Liters | Standard Error 0.116 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.448 Liters | Standard Error 0.117 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.603 Liters | Standard Error 0.116 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.212 Liters | Standard Error 0.108 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.514 Liters | Standard Error 0.109 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.455 Liters | Standard Error 0.111 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.626 Liters | Standard Error 0.119 |
| LAS100977 10 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.501 Liters | Standard Error 0.114 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 6 hr | 3.421 Liters | Standard Error 0.109 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 3 hr | 3.464 Liters | Standard Error 0.11 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.25 hr | 3.382 Liters | Standard Error 0.107 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.08 hr | 3.418 Liters | Standard Error 0.117 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 4 hr | 3.448 Liters | Standard Error 0.11 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Baseline | 3.190 Liters | Standard Error 0.106 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 12 hr | 3.367 Liters | Standard Error 0.115 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 0.5 hr | 3.441 Liters | Standard Error 0.11 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 24 hr | 3.295 Liters | Standard Error 0.107 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 8 hr | 3.469 Liters | Standard Error 0.116 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 23 hr | 3.257 Liters | Standard Error 0.106 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 14 hr | 3.348 Liters | Standard Error 0.118 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 2 36 hr | 3.274 Liters | Standard Error 0.105 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 2 hr | 3.415 Liters | Standard Error 0.108 |
| Indacaterol 150 μg | Absolute Forced Vital Capacity (FVC) Values | Day 1 1 hr | 3.415 Liters | Standard Error 0.111 |
Secondary
Absolute Inspiratory Capacity (IC) Values
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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.279 Liters | Standard Error 0.076 |
| Placebo | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.240 Liters | Standard Error 0.082 |
| Placebo | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.203 Liters | Standard Error 0.074 |
| LAS100977 0.625 μg | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.504 Liters | Standard Error 0.081 |
| LAS100977 0.625 μg | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.239 Liters | Standard Error 0.078 |
| LAS100977 0.625 μg | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.374 Liters | Standard Error 0.082 |
| LAS100977 2.5 μg | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.473 Liters | Standard Error 0.083 |
| LAS100977 2.5 μg | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.234 Liters | Standard Error 0.075 |
| LAS100977 2.5 μg | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.398 Liters | Standard Error 0.085 |
| LAS100977 5 μg | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.548 Liters | Standard Error 0.088 |
| LAS100977 5 μg | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.254 Liters | Standard Error 0.077 |
| LAS100977 5 μg | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.402 Liters | Standard Error 0.081 |
| LAS100977 10 μg | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.623 Liters | Standard Error 0.088 |
| LAS100977 10 μg | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.237 Liters | Standard Error 0.077 |
| LAS100977 10 μg | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.543 Liters | Standard Error 0.086 |
| Indacaterol 150 μg | Absolute Inspiratory Capacity (IC) Values | Baseline | 2.246 Liters | Standard Error 0.076 |
| Indacaterol 150 μg | Absolute Inspiratory Capacity (IC) Values | Day 2 24 hr | 2.380 Liters | Standard Error 0.077 |
| Indacaterol 150 μg | Absolute Inspiratory Capacity (IC) Values | Day 1 4 hr | 2.447 Liters | Standard Error 0.079 |
Secondary
Change From Baseline in 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) 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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.018 Liters | Standard Error 0.015 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | -0.018 Liters | Standard Error 0.019 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | -0.066 Liters | Standard Error 0.017 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | -0.047 Liters | Standard Error 0.017 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.007 Liters | Standard Error 0.016 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.475 Liters | Standard Error 0.059 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | -0.005 Liters | Standard Error 0.013 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | -0.005 Liters | Standard Error 0.017 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.015 Liters | Standard Error 0.014 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.018 Liters | Standard Error 0.014 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.002 Liters | Standard Error 0.016 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.006 Liters | Standard Error 0.013 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | -0.067 Liters | Standard Error 0.02 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.010 Liters | Standard Error 0.015 |
| Placebo | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | -0.020 Liters | Standard Error 0.02 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | 0.216 Liters | Standard Error 0.028 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.506 Liters | Standard Error 0.065 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.087 Liters | Standard Error 0.016 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | 0.036 Liters | Standard Error 0.023 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | 0.093 Liters | Standard Error 0.023 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | 0.040 Liters | Standard Error 0.024 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.126 Liters | Standard Error 0.019 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.151 Liters | Standard Error 0.02 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.166 Liters | Standard Error 0.022 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.201 Liters | Standard Error 0.022 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.225 Liters | Standard Error 0.021 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.169 Liters | Standard Error 0.025 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | 0.115 Liters | Standard Error 0.025 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | 0.099 Liters | Standard Error 0.026 |
| LAS100977 0.625 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | 0.044 Liters | Standard Error 0.011 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | 0.090 Liters | Standard Error 0.011 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | 0.189 Liters | Standard Error 0.027 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | 0.180 Liters | Standard Error 0.026 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | 0.276 Liters | Standard Error 0.024 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | 0.134 Liters | Standard Error 0.026 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.230 Liters | Standard Error 0.021 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.155 Liters | Standard Error 0.015 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | 0.104 Liters | Standard Error 0.022 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | 0.184 Liters | Standard Error 0.025 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.308 Liters | Standard Error 0.023 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.472 Liters | Standard Error 0.062 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.287 Liters | Standard Error 0.022 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.260 Liters | Standard Error 0.025 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.186 Liters | Standard Error 0.018 |
| LAS100977 2.5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.217 Liters | Standard Error 0.021 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.263 Liters | Standard Error 0.024 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.308 Liters | Standard Error 0.024 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.202 Liters | Standard Error 0.019 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | 0.276 Liters | Standard Error 0.022 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.161 Liters | Standard Error 0.015 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | 0.083 Liters | Standard Error 0.023 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.218 Liters | Standard Error 0.018 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | 0.214 Liters | Standard Error 0.24 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | 0.166 Liters | Standard Error 0.022 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.245 Liters | Standard Error 0.019 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | 0.205 Liters | Standard Error 0.021 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.483 Liters | Standard Error 0.063 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | 0.202 Liters | Standard Error 0.027 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.274 Liters | Standard Error 0.024 |
| LAS100977 5 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | 0.085 Liters | Standard Error 0.012 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | 0.236 Liters | Standard Error 0.027 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.191 Liters | Standard Error 0.019 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | 0.116 Liters | Standard Error 0.024 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.217 Liters | Standard Error 0.021 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | 0.271 Liters | Standard Error 0.026 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.240 Liters | Standard Error 0.023 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.261 Liters | Standard Error 0.024 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | 0.117 Liters | Standard Error 0.016 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.321 Liters | Standard Error 0.023 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.341 Liters | Standard Error 0.173 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | 0.311 Liters | Standard Error 0.031 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.493 Liters | Standard Error 0.065 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.313 Liters | Standard Error 0.025 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | 0.211 Liters | Standard Error 0.03 |
| LAS100977 10 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | 0.250 Liters | Standard Error 0.026 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 3 hr | 0.184 Liters | Standard Error 0.02 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.25 hr | 0.132 Liters | Standard Error 0.016 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 8 hr | 0.124 Liters | Standard Error 0.021 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 2 hr | 0.161 Liters | Standard Error 0.019 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 12 hr | 0.085 Liters | Standard Error 0.023 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.08 hr | 0.103 Liters | Standard Error 0.014 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 24 hr | 0.088 Liters | Standard Error 0.02 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 23 hr | 0.050 Liters | Standard Error 0.022 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 14 hr | 0.087 Liters | Standard Error 0.022 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 1 hr | 0.156 Liters | Standard Error 0.016 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 0.5 hr | 0.150 Liters | Standard Error 0.017 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 6 hr | 0.135 Liters | Standard Error 0.018 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 2 36 hr | 0.036 Liters | Standard Error 0.021 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline | 1.488 Liters | Standard Error 0.064 |
| Indacaterol 150 μg | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Day 1 4 hr | 0.179 Liters | Standard Error 0.018 |
Secondary
Change From Baseline in 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) 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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | -0.093 Liters | Standard Error 0.037 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | -0.110 Liters | Standard Error 0.043 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.020 Liters | Standard Error 0.026 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | -0.076 Liters | Standard Error 0.035 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.016 Liters | Standard Error 0.03 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | -0.023 Liters | Standard Error 0.037 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.127 Liters | Standard Error 0.085 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | -0.035 Liters | Standard Error 0.038 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.036 Liters | Standard Error 0.035 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.165 Liters | Standard Error 0.101 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.036 Liters | Standard Error 0.034 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.048 Liters | Standard Error 0.026 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.052 Liters | Standard Error 0.029 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.048 Liters | Standard Error 0.037 |
| Placebo | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.004 Liters | Standard Error 0.027 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.098 Liters | Standard Error 0.027 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.224 Liters | Standard Error 0.041 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.140 Liters | Standard Error 0.033 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.340 Liters | Standard Error 0.048 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | 0.107 Liters | Standard Error 0.047 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.191 Liters | Standard Error 0.035 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.242 Liters | Standard Error 0.041 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.248 Liters | Standard Error 0.044 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | 0.063 Liters | Standard Error 0.04 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | 0.090 Liters | Standard Error 0.039 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.263 Liters | Standard Error 0.045 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | 0.198 Liters | Standard Error 0.048 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | 0.039 Liters | Standard Error 0.042 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.297 Liters | Standard Error 0.042 |
| LAS100977 0.625 μg | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.195 Liters | Standard Error 0.104 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.379 Liters | Standard Error 0.039 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.309 Liters | Standard Error 0.044 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.327 Liters | Standard Error 0.044 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | 0.186 Liters | Standard Error 0.038 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.193 Liters | Standard Error 0.037 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.232 Liters | Standard Error 0.037 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.137 Liters | Standard Error 0.102 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | 0.153 Liters | Standard Error 0.05 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.263 Liters | Standard Error 0.043 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | 0.236 Liters | Standard Error 0.05 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.0269 Liters | Standard Error 0.04 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.166 Liters | Standard Error 0.034 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.338 Liters | Standard Error 0.041 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | 0.114 Liters | Standard Error 0.045 |
| LAS100977 2.5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | 0.259 Liters | Standard Error 0.046 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.337 Liters | Standard Error 0.042 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.178 Liters | Standard Error 0.027 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.212 Liters | Standard Error 0.033 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.263 Liters | Standard Error 0.036 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.241 Liters | Standard Error 0.036 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.300 Liters | Standard Error 0.035 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.325 Liters | Standard Error 0.041 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.153 Liters | Standard Error 0.094 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.348 Liters | Standard Error 0.042 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.335 Liters | Standard Error 0.04 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | 0.272 Liters | Standard Error 0.05 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | 0.266 Liters | Standard Error 0.043 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | 0.187 Liters | Standard Error 0.044 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | 0.207 Liters | Standard Error 0.039 |
| LAS100977 5 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | 0.059 Liters | Standard Error 0.038 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.392 Liters | Standard Error 0.039 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | 0.244 Liters | Standard Error 0.051 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.212 Liters | Standard Error 0.108 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | 0.315 Liters | Standard Error 0.046 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.264 Liters | Standard Error 0.036 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | 0.329 Liters | Standard Error 0.048 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | 0.140 Liters | Standard Error 0.04 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | 0.243 Liters | Standard Error 0.046 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.289 Liters | Standard Error 0.042 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.303 Liters | Standard Error 0.042 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.415 Liters | Standard Error 0.044 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.277 Liters | Standard Error 0.037 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.267 Liters | Standard Error 0.04 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.425 Liters | Standard Error 0.05 |
| LAS100977 10 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.402 Liters | Standard Error 0.035 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 8 hr | 0.266 Liters | Standard Error 0.046 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 3 hr | 0.274 Liters | Standard Error 0.037 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Baseline | 3.190 Liters | Standard Error 0.106 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 12 hr | 0.182 Liters | Standard Error 0.047 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 2 hr | 0.244 Liters | Standard Error 0.036 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 1 hr | 0.246 Liters | Standard Error 0.041 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 14 hr | 0.148 Liters | Standard Error 0.045 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.5 hr | 0.246 Liters | Standard Error 0.036 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 36 hr | 0.084 Liters | Standard Error 0.04 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 23 hr | 0.063 Liters | Standard Error 0.041 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.25 hr | 0.192 Liters | Standard Error 0.035 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 0.08 hr | 0.221 Liters | Standard Error 0.034 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 2 24 hr | 0.100 Liters | Standard Error 0.04 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 6 hr | 0.231 Liters | Standard Error 0.036 |
| Indacaterol 150 μg | Change From Baseline in Forced Vital Capacity (FVC) | Day 1 4 hr | 0.254 Liters | Standard Error 0.035 |
Secondary
Change From Baseline in Inspiratory Capacity (IC)
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
Time frame: Up to Day 2
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.004 Liters | Standard Error 0.037 |
| Placebo | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.240 Liters | Standard Error 0.082 |
| Placebo | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | -0.047 Liters | Standard Error 0.04 |
| LAS100977 0.625 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.260 Liters | Standard Error 0.039 |
| LAS100977 0.625 μg | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.239 Liters | Standard Error 0.078 |
| LAS100977 0.625 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | 0.110 Liters | Standard Error 0.037 |
| LAS100977 2.5 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.239 Liters | Standard Error 0.04 |
| LAS100977 2.5 μg | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.234 Liters | Standard Error 0.075 |
| LAS100977 2.5 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | 0.157 Liters | Standard Error 0.037 |
| LAS100977 5 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.316 Liters | Standard Error 0.043 |
| LAS100977 5 μg | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.254 Liters | Standard Error 0.077 |
| LAS100977 5 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | 0.174 Liters | Standard Error 0.038 |
| LAS100977 10 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.370 Liters | Standard Error 0.043 |
| LAS100977 10 μg | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.237 Liters | Standard Error 0.077 |
| LAS100977 10 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | 0.273 Liters | Standard Error 0.046 |
| Indacaterol 150 μg | Change From Baseline in Inspiratory Capacity (IC) | Baseline | 2.246 Liters | Standard Error 0.076 |
| Indacaterol 150 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 2 24 hr | 0.136 Liters | Standard Error 0.035 |
| Indacaterol 150 μg | Change From Baseline in Inspiratory Capacity (IC) | Day 1 4 hr | 0.215 Liters | Standard Error 0.036 |
Secondary
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
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
Time frame: Day 1
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | -0.062 Liters | Standard Error 0.016 |
| Placebo | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | -0.032 Liters | Standard Error 0.013 |
| Placebo | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | -0.003 Liters | Standard Error 0.012 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | 0.168 Liters | Standard Error 0.021 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | 0.077 Liters | Standard Error 0.023 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | 0.121 Liters | Standard Error 0.021 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | 0.243 Liters | Standard Error 0.021 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | 0.205 Liters | Standard Error 0.022 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | 0.166 Liters | Standard Error 0.024 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | 0.222 Liters | Standard Error 0.021 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | 0.196 Liters | Standard Error 0.021 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | 0.247 Liters | Standard Error 0.021 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | 0.235 Liters | Standard Error 0.021 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | 0.288 Liters | Standard Error 0.022 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | 0.262 Liters | Standard Error 0.024 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-12 | 0.134 Liters | Standard Error 0.017 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC0-24 | 0.104 Liters | Standard Error 0.018 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve | Change from baseline in FEV1 AUC12-24 | 0.073 Liters | Standard Error 0.021 |
Secondary
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
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
Time frame: Day 1
Population: 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
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | -0.034 Liters | Standard Error 0.027 |
| Placebo | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.026 Liters | Standard Error 0.026 |
| Placebo | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | -0.096 Liters | Standard Error 0.031 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | 0.170 Liters | Standard Error 0.036 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.253 Liters | Standard Error 0.037 |
| LAS100977 0.625 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | 0.089 Liters | Standard Error 0.039 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | 0.253 Liters | Standard Error 0.039 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.297 Liters | Standard Error 0.036 |
| LAS100977 2.5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | 0.208 Liters | Standard Error 0.045 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | 0.272 Liters | Standard Error 0.035 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.306 Liters | Standard Error 0.034 |
| LAS100977 5 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | 0.236 Liters | Standard Error 0.039 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | 0.328 Liters | Standard Error 0.038 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.372 Liters | Standard Error 0.037 |
| LAS100977 10 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | 0.284 Liters | Standard Error 0.042 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-12 | 0.237 Liters | Standard Error 0.033 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC12-24 | 0.114 Liters | Standard Error 0.037 |
| Indacaterol 150 μg | Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve | Change from baseline in FVC AUC0-24 | 0.175 Liters | Standard Error 0.033 |
Secondary
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) 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
Time frame: Day 1
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.098 Liters | Standard Error 0.016 |
| LAS100977 0.625 μg | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.290 Liters | Standard Error 0.025 |
| LAS100977 2.5 μg | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.351 Liters | Standard Error 0.022 |
| LAS100977 5 μg | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.350 Liters | Standard Error 0.023 |
| LAS100977 10 μg | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.391 Liters | Standard Error 0.024 |
| Indacaterol 150 μg | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.263 Liters | Standard Error 0.019 |
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) 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
Time frame: Day 1
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.332 Liters | Standard Error 0.05 |
| LAS100977 0.625 μg | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.484 Liters | Standard Error 0.05 |
| LAS100977 2.5 μg | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.523 Liters | Standard Error 0.05 |
| LAS100977 5 μg | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.532 Liters | Standard Error 0.05 |
| LAS100977 10 μg | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.575 Liters | Standard Error 0.05 |
| Indacaterol 150 μg | Change From Baseline in Peak Forced Vital Capacity (FVC) | 0.470 Liters | Standard Error 0.05 |
Secondary
Change From Baseline in 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
Time frame: Day 2
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) | -0.079 Liters | Standard Error 0.044 |
| LAS100977 0.625 μg | Change From Baseline in Trough Forced Vital Capacity (FVC) | 0.067 Liters | Standard Error 0.044 |
| LAS100977 2.5 μg | Change From Baseline in Trough Forced Vital Capacity (FVC) | 0.180 Liters | Standard Error 0.044 |
| LAS100977 5 μg | Change From Baseline in Trough Forced Vital Capacity (FVC) | 0.217 Liters | Standard Error 0.044 |
| LAS100977 10 μg | Change From Baseline in Trough Forced Vital Capacity (FVC) | 0.254 Liters | Standard Error 0.044 |
| Indacaterol 150 μg | Change From Baseline in Trough Forced Vital Capacity (FVC) | 0.088 Liters | Standard Error 0.044 |
Secondary
Time to Peak Forced Expiratory Volume in One Second (FEV1)
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
Time frame: Day 1
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 2.5 Hours | Standard Error 0.2 |
| LAS100977 0.625 μg | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 3.4 Hours | Standard Error 0.2 |
| LAS100977 2.5 μg | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 3.5 Hours | Standard Error 0.2 |
| LAS100977 5 μg | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 3.7 Hours | Standard Error 0.2 |
| LAS100977 10 μg | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 4.0 Hours | Standard Error 0.2 |
| Indacaterol 150 μg | Time to Peak Forced Expiratory Volume in One Second (FEV1) | 2.9 Hours | Standard Error 0.2 |
Secondary
Time to Peak Forced Vital Capacity (FVC)
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
Time frame: Day 1
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Peak Forced Vital Capacity (FVC) | 2.4 Hours | Standard Error 0.3 |
| LAS100977 0.625 μg | Time to Peak Forced Vital Capacity (FVC) | 3.6 Hours | Standard Error 0.3 |
| LAS100977 2.5 μg | Time to Peak Forced Vital Capacity (FVC) | 3.4 Hours | Standard Error 0.2 |
| LAS100977 5 μg | Time to Peak Forced Vital Capacity (FVC) | 3.1 Hours | Standard Error 0.2 |
| LAS100977 10 μg | Time to Peak Forced Vital Capacity (FVC) | 3.6 Hours | Standard Error 0.3 |
| Indacaterol 150 μg | Time to Peak Forced Vital Capacity (FVC) | 2.6 Hours | Standard Error 0.3 |