Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2

Inclusion criteria:

The following inclusion criteria apply at Visit 0:

1. All subjects must sign an informed consent consistent with the International
Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to
participation in the trial and conducting any study procedures

2. Male or female subjects 40 years of age or older.

3. Hospitalization for a primary diagnosis of acute COPD exacerbation for =14 days.
Determination of accuracy of admission diagnosis will be at the discretion of the
investigator.

4. Patient reported hospital length of stay and discharge date (confirmed with hospital
discharge summary/hospital records; however, medical record confirmation may occur
following randomization).

The following inclusion criteria apply at Visit 1:

5. Discharged from the hospital =10 days from date of randomization.

6. All subjects must have a diagnosis of COPD (P12-01205), and have documented airway
obstruction with a post-bronchodilator Force Expiratory Volume in 1 second (FEV1)\
Force vital capacity (FVC) <0.7(See Section 5.1.2, Pulmonary Function Testing). The
diagnosis of COPD can be made at Visit 1 if no Pulmonary Function Testing (PFT) data
available within the past 12 months.

7. Subjects must be current or ex-smoker with a smoking history of =10 pack-years:

Pack-years = Number of cigarettes/day x years of smoking 20 cigarettes/ pack 8. Subjects
must be able to inhale medication in a competent manner from the HandiHaler® device
(Appendix 10.1) and from a metered dose inhaler (MDI).

Exclusion criteria:

The following exclusion criterion applies at Visit 0:

1. No more than 30 days of therapy with any long-acting inhaled anticholinergic over
preceding 3 months prior to discharge from the hospital, and no therapy with any long
acting anticholinergic post discharge (no use between hospital discharge and
randomization) or any other restricted concomitant medications

The following exclusion criteria apply at Visit 1:

2. Presence of a significant disease (in the opinion of the investigator) which may put
the subject at risk because of participation in the study or may influence the
subject's ability to participate in the study for up to 2 years.

3. A documented history of myocardial infarction during the hospitalization preceding
randomization. Subjects being stable with a history of cardiac stents are permitted.

4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change
in drug therapy during the last year.

5. Subjects with asthma (subject treated for asthma in the last 2 years, history of
childhood asthma is permitted), cystic fibrosis, clinical diagnosis of bronchiectasis,
interstitial lung disease, pulmonary thromboembolic disease or known active
tuberculosis.

7. Malignancy for which the subject has undergone resection, radiation, chemotherapy or
biological treatments within the last two years or is currently on active radiation
therapy, chemotherapy or biological treatment. Subjects with treated basal cell carcinoma
and non-invasive squamous cell skin carcinoma are allowed.

8. Hospitalization for cardiac failure (New York Heart Association (NYHA) class III or IV)
during the hospitalization preceding randomization.

9. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the
HandiHaler® or MDI inhalation solution delivery system.

10. Known moderate to severe renal impairment as judged by the investigator. 11. Known
narrow angle glaucoma as judged by the investigator. 12. Significant symptomatic prostatic
hyperplasia or bladder-neck obstruction. Subjects whose symptoms are controlled on
treatment may be included.

13. Pregnant or nursing women or women of childbearing potential not using a medically
approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm
or sub dermal implants e.g., Norplant®) for at least three months prior to and for the
duration of the trial.

14. Significant alcohol or drug abuse within the past 12 months. 15. Previously randomized
in this study or currently participating in another interventional study.

16. Visual impairment that as judged by the investigator does not allow the subject to
independently read and complete the questionnaires and eDiary.

17. Any significant or new ECG findings at Visit 1 as judged by the investigator,
including, but not limited to signs of acute ischemia, arrhythmia.

18. Treatment with any restricted pulmonary medication. 19. Residing in an assisted living
facility.