Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Inclusion criteria:

- Male or female patients, 40 years of age or older.

- Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in
one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced
vital capacity (FVC) <70% at Visit 1

- Documented history of at least one moderate to severe COPD exacerbation in the
previous 12 months requiring treatment with systemic corticosteroids and/or
antibiotics and/or related hospitalization.

- Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use
of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of
change in their usual COPD medication 4 weeks prior to visit 1.

- Current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria:

- Significant disease other than COPD.

- Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2
ULN will be excluded regardless of clinical condition. ( A repeat laboratory
evaluation can be conducted if deemed necessary by the investigator.)

- Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy,
source documentation is required to verify that the patient does not have asthma

- A diagnosis of thyrotoxicosis

- A history of myocardial infarction within 6 months of screening visit.

- Life-threatening cardiac arrhythmia.

- Known active tuberculosis.

- Any malignancy unless free of disease for at least 5 years (patients with treated
basal cell carcinoma or squamous cell skin cancers are allowed).

- A history of cystic fibrosis.

- Clinically relevant bronchiectasis.

- Patients with severe emphysema requiring endobronchial interventions within 6 months
prior to screening

- A history of significant alcohol or drug abuse in the opinion of the investigator.

- Patients who have undergone thoracotomy with pulmonary resection

- Patients being treated with oral or patch ß-adrenergics.

- Patients being treated with oral corticosteroid medication at unstable doses

- Patients being treated with antibiotics for any reasons within 4 weeks of screening
visit

- Patients being treated with PDE4 inhibitors within 3 months of screening visit

- Patients who have taken an investigational drug within one month or six half-lives

- Pregnant or nursing women.

- Women of childbearing potential not using a highly effective method of birth control.