| Primary | Pre-dose FEV1 | Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.050(1.030 to 1.070)
- OG0011.006(0.987 to 1.025)
|
|
| | 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 | multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate | 0.0004 | | Ratio | 1.044 | | | 2-Sided | 95 | 1.019 | 1.069 | | | | No | Superiority or Other | | |
|
| Secondary | Post-dose FEV1 at 5 Minutes | Ratio of post-dose FEV1 at 5 minutes to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose FEV1 at 60 Minutes | Ratio of post-dose FEV1 at 60 minutes to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Pre-dose FVC | Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose FVC at 5 Minutes | Ratio of post-dose FVC at 5 minutes to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12) | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose FVC at 60 Minutes | Ratio of post-dose FVC at 60 minutes to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Pre-dose IC | Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose IC at 60 Minutes | Ratio of post-dose IC at 60 minutes to baseline value | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12) | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Pre-dose PEF in Last Week of Treatment | Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Pre-dose PEF in First Week of Treatment | Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Pre-dose PEF in Whole Treatment Period | Change in pre-dose morning PEF from run-in period to whole treatment period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose PEF in Last Week of Treatment | Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose PEF in First Week of Treatment | Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Post-dose PEF in Whole Treatment Period | Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | L/min | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Day in the Last Week on Treatment | Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Day in the First Week on Treatment | Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Day in the Whole Treatment Period | Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Night in the Last Week on Treatment | Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Night in the First Week on Treatment | Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Use of Reliever Medication During Night in the Whole Treatment Period | Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | times/day | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Change in COPD Symptoms - Breathing | Change in breathing symptom score (from 0:none to 4:severe) from run-in period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Change in COPD Symptoms - Cough | Change in Cough symptom score (from 0:none to 4:severe) from run-in period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | Change in COPD Symptoms - Sputum | Change in Sputum symptom score (from 0:none to 4:severe) from run-in period | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |
| Secondary | COPD Exacerbations | Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms | FAS (287 + 290); less number of patients analyzed was caused by missing values. | Posted | | Least Squares Mean | 95% Confidence Interval | exacerbations/participant/12 weeks | | Whole treatment period of 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Symbicort+Spiriva | Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily) | | OG001 | Spiriva | Spiriva 18 μg/inhalation, 1 inhalation once daily |
| |