A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

Exclusion Criteria

• •Diagnosis of asthma or other respiratory disorders
• •Maintenance bronchodilators therapy only (eg LABA alone)
• •Maintenance triple therapy.
• •Occurrence of a moderate or severe COPD exacerbation within 6 weeks prior to study entry or during the run-in period.
• •Patients requiring long term oxygen therapy.
• •Concomitant or recent pulmonary rehabilitation programme
• •Known respiratory disorders other than COPD
• •Lung cancer or a history of lung cancer, active or history of cancer with less than 5 years disease free survival time
• •Hypersensitivity to β2-agonist, corticosteroids, PDE4 inhibitors or any of the excipients
• •Depression, generalised anxiety disorder, suicidal ideation
• •Any clinically significant cardiovascular disease (IM, CHF III/IV; AF not controlled by therapy, etc) within 1 year of study entry
• •Any relevant clinically significant cardiovascular condition, clinically abnormal significant 12-lead ECG (QTcF\>450 ms for male and \>470 for female) or clinically significant laboratory abnormalities
• •Serum potassium value ≤3.5 mEq/L or \>5.5mEq/L and/or a fasting serum glucose value ≥140 mg/dL.
• •History or symptoms of significant neurological disease
• •Unstable concurrent disease: eg uncontrolled Thyroid disease or other endocrine diseases, gastrointestinal uncontrolled disease, uncontrolled immune diseases
• •Renal impairment.
• •Patients with abnormal alanine aminotransferase and/ or aspartate aminotransferase and/or bilirubin
• •Current or chronic history of liver disease, or known hepatic or biliary abnormalities and patients receiving treatment with any drug known to have a well defined potential for hepatotoxicity before Study entry
• •Severely obese (BMI ≥35 kg/m2) or have experienced excessive weight loss recently
• •History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
• •Any recent participation to a clinical Study with other investigational drug