- FEV1 AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 1 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
- FEV1 AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
- FEV1 AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
- FEV1 AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
- FEV1 AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
- FEV1 AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
- FEV1 AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
- FEV1 AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
- FEV1 AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
- Peak FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
- Peak FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
- Peak FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
- Peak FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval on Day 85 ]
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
- Time to Onset of Therapeutic FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
- Time to Onset of Therapeutic FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
- Time to Onset of Therapeutic FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
- Time to Onset of Therapeutic FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
- Duration of Therapeutic FEV1 Response at Day 1 [ Time Frame: During the 6-hour observation period after drug administration at Day 1 ]
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
- Duration of Therapeutic FEV1 Response at Day 29 [ Time Frame: During the 6-hour observation period after drug administration at Day 29 ]
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
- Duration of Therapeutic FEV1 Response at Day 57 [ Time Frame: During the 6-hour observation period after drug administration at Day 57 ]
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
- Duration of Therapeutic FEV1 Response at Day 85 [ Time Frame: During the 6-hour observation period after drug administration at Day 85 ]
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
- Time to Peak FEV1 Response at Day 1 [ Time Frame: Within the 6-hour post-treatment observation period at Day 1 ]
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
- Time to Peak FEV1 Response at Day 29 [ Time Frame: Within the 6-hour post-treatment observation period at Day 29 ]
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
- Time to Peak FEV1 Response at Day 57 [ Time Frame: Within the 6-hour post-treatment observation period at Day 57 ]
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
- Time to Peak FEV1 Response at Day 85 [ Time Frame: Within the 6-hour post-treatment observation period at Day 85 ]
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
- FVC AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 1 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
- FVC AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 29 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
- FVC AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
- FVC AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
- FVC AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
- FVC AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
- FVC AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
- FVC AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
- FVC AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
- FVC AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
- FVC AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
- FVC AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
- Peak FVC Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
- Peak FVC Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
- Peak FVC Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
- Peak FVC Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
- Rescue Medication Use on Pulmonary Test Day 1 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 1 ]
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
- Rescue Medication Use on Pulmonary Test Day 29 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 29 ]
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
- Rescue Medication Use on Pulmonary Test Day 57 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 57 ]
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
- Rescue Medication Use on Pulmonary Test Day 85 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 85 ]
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
- Night-time Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
- Daytime Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
- Night-time Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period)
- Daytime Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period)
- Trough Peak Expiratory Flow Rate (PEFR) [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
- Trough PEFR [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Time Frame: Prior to pulmonary function test on Day 29 ]
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Time Frame: Prior to pulmonary function test on Day 57 ]
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
- Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Time Frame: Prior to pulmonary function test on Day 85 ]
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.
- Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
COPD excerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
- COPD Excerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
COPD excerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Purpose
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