Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

Inclusion criteria

• Male or female patient ≥ 30 years old
• Patient with BMI ≥ 20
• Written informed consent obtained
• Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study.
• Patient should be treated according to GOLD guidelines
• COPD patient with GOLD stages III until IV
• Patient with smoking history of at least 10 pack-years
• Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1
• Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.

Exclusion criteria

• Pregnant or lactating females
• Patient with severe immunological diseases and/ or severe acute infectious diseases.
• Patient with heart failure
• Patient with diagnosis of cancer (except basal cell carcinoma)
• Patient with a history of depression associated with suicidal ideation or behaviour
• Patient with moderate or severe hepatic impairment.
• Patient with lactose intolerance
• Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
• Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).