| Primary | Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) | | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | 95% Confidence Interval | Liters | | 24 hours following two weeks of dosing. | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG0000.104(0.054 to 0.155)
- OG0010.080(0.035 to 0.124)
- OG0020.221(0.175 to 0.267)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | Study baseline FEV1 as covariate and treatment group as fixed effect. | <0.001 | | | | | | | 95 | | | | | | No | Superiority or Other | | | | | ANCOVA | Study Baseline FEV1 as a covariate and treatment group as a fixed effect. |
|
| Secondary | Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B) | | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | 95% Confidence Interval | Liters | | 0-12 hours following two weeks of dosing | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B) | | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | 95% Confidence Interval | Liters | | Following 2 weeks of dosing | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough) | Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1. | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | 95% Confidence Interval | Liters | | Following 2 weeks of dosing | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication | Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1. | | Posted | | Mean | Standard Deviation | Liters | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication | Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted. | | Posted | | Mean | Standard Deviation | Percent of predicted FEV1 | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline | 12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment. | | Posted | | Mean | 95% Confidence Interval | Liters | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks | Analyzed from end of dosing to 12 hours. | Total number of subjects in each arm: 76, 80, 78. | Posted | | Median | Full Range | Hours | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks | Analyzed from end of dosing to 12 hours. | Total number of subjects in each arm: 76, 80, 78. | Posted | | Median | Full Range | Hours | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing | Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC. | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | 95% Confidence Interval | Liters | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint | | | Posted | | Mean | Standard Deviation | Liters | | 2 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week | Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol. | | Posted | | Mean | 95% Confidence Interval | Days per week | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day | Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period. | | Posted | | Mean | 95% Confidence Interval | Actuations per day | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Transition Dyspnea Index (TDI) Focal Score | TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement. | Total number of subjects in each arm: 76, 80, 78 | Posted | | Mean | Standard Deviation | Units on a scale | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score | A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important. | Total number of subjects in each arm: 76, 80, 78 | Posted | | Number | | Participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |
| Secondary | Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score | A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important. | Total number of subjects in each arm: 76, 80, 78 | Posted | | Number | | Percentage of participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Arformoterol 15 Mcg Twice Daily | Arformoterol 15 mcg twice daily/Placebo Inhalation Powder | | OG001 | Tiotropium 18 Mcg Once Daily | Tiotropium 18 mcg once daily/Placebo Inhalation Solution | | OG002 | Arformoterol /Tiotropium | Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily |
| |