Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

- Male and female subjects ≥40 years and ≤85 years of age at the time of consent.

- Subject must have a primary diagnosis of mild or moderate COPD defined as
post-bronchodilator FEV1/FVC ratio of <70% and FEV1 of ≥50% of predicted normal value
as per the NHANES III predicted normal values at screening.

- Willing to stop all other COPD medications or other medications which will interfere
with the study results for the entire duration of the study, except
albuterol/salbutamol as needed.

- Current or ex-smoker with ≥10 pack-year smoking history.

Exclusion Criteria:

- Subjects with a chest x-ray/CT scan that suggests a diagnosis other than COPD (eg,
pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing
pulmonary conditions) and taken within 6 months prior to study start. If there is no
chest x-ray or CT scan taken within 6 months prior to study start, or if recent
results are unavailable for review, a chest x-ray must be performed.

- Use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot
corticosteroids within 3 months prior to screening or subject has had a change in dose
or type of any medications for COPD within 14 days before screening.

- Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening.

- Subjects with a history of asthma, with the exception of outgrown childhood asthma,
defined as transient wheezers outgrown by 5 years of age.

- Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.

- Subject requires nocturnal oxygen or continuous supplemental oxygen therapy.

- Subject with history of a positive result for HBsAg or HCV antibody.

- Subject is known to be seropositive for human immunodeficiency virus.

- Female subject is pregnant or lactating.

- Subject has a history of allergic reaction to the anti-cholinergic or any components
of the study medications.