| Primary | FEV1 AUC0-6 at Day 85 | 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 85 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.145± 0.007
- OG0010.149± 0.007
- OG0020.119± 0.007
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.7135 | | Mean Difference (Final Values) | -0.0035 | Standard Error of the Mean | 0.0095 | | 95 | -0.0222 | 0.0152 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority margin is 0.05 liter | |
|
| Primary | FEV1 AUC0-4 at Day 85 | 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 85 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Primary | FEV1 AUC4-6 at Day 85 | 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 85 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-6 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-6 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-6 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FEV1 AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FEV1 Response at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Onset of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the first 2-hour post-treatment interval at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Onset of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the first 2-hour post-treatment interval at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Onset of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the first 2-hour post-treatment interval at Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Onset of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the first 2-hour post-treatment interval at Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Duration of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | During the 6-hour observation period after drug administration at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Duration of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | During the 6-hour observation period after drug administration at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Duration of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | During the 6-hour observation period after drug administration at Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Duration of Therapeutic FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | During the 6-hour observation period after drug administration at Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Peak FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the 6-hour post-treatment observation period at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Peak FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the 6-hour post-treatment observation period at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Peak FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the 6-hour post-treatment observation period at Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Time to Peak FEV1 Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Median | Inter-Quartile Range | Minutes | | Within the 6-hour post-treatment observation period at Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-6 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-6 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-6 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-6 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 6 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC0-4 at 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Before drug administration to 4 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | FVC AUC4-6 at 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 | Full Analysis Set for Pulmonary Function Test Data 4-6 hours | Posted | | Least Squares Mean | Standard Error | liters | | Between 4 hours and 6 hours after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Peak FVC Response 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 | Full Analysis Set for Pulmonary Function Test Data | Posted | | Least Squares Mean | Standard Error | liters | | Within the first 2-hour post-treatment interval at Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Rescue Medication Use on Pulmonary Test Day 1 | Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1 | | Posted | | Number | | patients | | During the 6-hour pulmonary function testing after drug administration on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Rescue Medication Use on Pulmonary Test Day 29 | Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29 | | Posted | | Number | | patients | | During the 6-hour pulmonary function testing after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Rescue Medication Use on Pulmonary Test Day 57 | Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57 | | Posted | | Number | | patients | | During the 6-hour pulmonary function testing after drug administration on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Rescue Medication Use on Pulmonary Test Day 85 | Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85 | | Posted | | Number | | patients | | During the 6-hour pulmonary function testing after drug administration on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Night-time Rescue Medication Use | 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) | Full Analysis Set for Diary Data | Posted | | Least Squares Mean | Standard Error | puffs | | During the 2-week baseline washout period and the 12-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Daytime Rescue Medication Use | The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period) | Full Analysis Set for Diary Data | Posted | | Least Squares Mean | Standard Error | puffs | | During the 2-week baseline washout period and the 12-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Night-time Symptom Score | The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period). Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night | Full Analysis Set for Diary Data | Posted | | Least Squares Mean | Standard Error | units on a scale | | During the 2-week baseline washout period and the 12-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Daytime Symptom Score | The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period). Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities | Full Analysis Set for Diary Data | Posted | | Least Squares Mean | Standard Error | units on a scale | | During the 2-week baseline washout period and the 12-week treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Trough Peak Expiratory Flow Rate (PEFR) | The weekly mean trough PEFR during the entire study (including baseline and on-treatment period) | Full Analysis Set for Diary Data | Posted | | Least Squares Mean | Standard Error | liters/min | | During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Physician's Global Evaluation Score on Pulmonary Function Testing 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. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | Prior to pulmonary function test on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Physician's Global Evaluation Score on Pulmonary Function Testing 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. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | Prior to pulmonary function test on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Physician's Global Evaluation Score on Pulmonary Function Testing 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. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | Prior to pulmonary function test on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period | COPD exacerbation 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. | | Posted | | Number | | Percentage of patients | | During the 12-week on-treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | COPD Exacerbation Rate During the On-treatment Period | Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation 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. | | Posted | | Number | | Proportion of patients | | During the 12-week on-treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | COPD Exacerbation During the On-treatment Period | COPD exacerbation 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. | | Posted | | Number | | Percentage of patients | | During the 12-week on-treatment period | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Frequency Distribution of Satisfaction Rating With Inhaler Attributes | | Treated set (US patients) | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler | Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied. | Treated set (US patients) | Posted | | Mean | Standard Error | units on a scale | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | MDI Device | | | OG001 | RESPIMAT Device | |
| |
| Secondary | Device Preference (Respimat or MDI) | Frequency of patients due to device preference | Treated set (US patients) | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Number of Patients | Total number of patients due to device preference |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Rating of Action of Turning Clear Base of Respimat | Frequency of patients due to rating of action of turning clear base of Respimat | Treated set (US patients) | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Number of Patients | Total number of patients due to rating of turning |
| | |
| Secondary | Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State | Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose). | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | | Before drug administration to 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Noncompartmental Parameters of Albuterol at Steady State | Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose). | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Before drug administration to 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat |
| |
| Secondary | Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours | Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg | | Before drug administration to 2 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 Mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours | Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss. | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg | | Before drug administration to 2 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat |
| |
| Secondary | Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours | Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg | | Before drug administration to 6 hours after drug administration on Day 26 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat | | OG002 | Ipratropium Respimat 20 mcg | Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI |
| |
| Secondary | Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours | Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss | All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg | | Before drug administration to 6 hours after drug administration on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | COMBIVENT Respimat 20/100 mcg | Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI | | OG001 | COMBIVENT CFC-MDI 36/206 mcg | COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat |
| |