Ensayos clínicos

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/FVC (Forced vital capacity) <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 regardless of clinical condition ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator)
• Current documented diagnosis of asthma
• For 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
• 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
• Have undergone thoracotomy with pulmonary resection
• Treated with oral or patch ß-adrenergics
• Treated with oral corticosteroid medication at unstable doses
• Treated with antibiotics for any reasons within 4 weeks of screening visit
• Treated with PDE4 inhibitors within 3 months of screening visit
• 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