Tiotropium / Respimat One Year Study in COPD.

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 [ Time Frame: Baseline and Day 337 ]
  Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
• Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ]
  Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 [ Time Frame: Baseline and Day 169 ]
  Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
• Number of COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
• Number of COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
• Number of Patients With at Least One COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
• Time to First Hospitalisation for COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
• Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
• Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
• Number of Patients With at Least One Hospitalisation for a COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
  Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
• Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 [ Time Frame: Baseline and Day 337 ]
  The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
• Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 [ Time Frame: Baseline and Day 169 ]
  The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
• Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 [ Time Frame: Baseline and Day 29 ]
  Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
• Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 [ Time Frame: Baseline and Day 169 ]
  Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
• Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 [ Time Frame: Baseline and Day 337 ]
  Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

• Device: Respimat
• Drug: Tiotropium

• Tiotropium
  Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
  Intervention: Drug: Tiotropium
• Placebo
  Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
  Intervention: Device: Respimat

Inclusion Criteria:

1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history > 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.