Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Open-label, Prospective Exploratory Study to Assess the Effects of Formoterol and Beclometasone Dipropionate Combination Therapy on Central and Peripheral Airway Dimensions in COPD Patients

The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on lung function (spirometry, body plethysmography), the BODE index, COPD assessment test (CAT) and Borg CR10 scale will be assessed and the safety will be evaluated.

Inclusion Criteria:

• Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years Decreased Tiffeneau index: FEV1/FVC < 0.70

• Male or female patients aged ≥ 40 years
• Patients should be treated according to the 'Global initiative for chronic Obstructive Lung Disease' (GOLD) guidelines
• Patients who present
• Moderate COPD with an FEV1 between 50 and 80% of predicted GOLD 2)
• Severe COPD with an FEV1 between 30 and 50% of predicted (GOLD 3)
• Very severe COPD with an FEV1 lower than 30% of predicted (GOLD 4)
• Patients will be maintained on stable respiratory medications for 6 weeks prior to screening
• Patients with a co-operative attitude and ability to be trained to correctly use the pMDI
• Written informed consent obtained

Exclusion Criteria:

• Pregnant or lactating females or females at risk of pregnancy
• Unstable patients who developed an exacerbation during the last 4 weeks
• Inability to carry out pulmonary function testing
• Diagnosis of asthma as defined by the current 'Global Initiative for Asthma' (GINA) guidelines
• Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
• Patients with a QTc interval (Bazett's formula) at the screening visit electrocardiogram (ECG) test >450 msec
• Cancer or any other chronic disease with poor prognosis and /or affecting patient status
• History of alcohol or drug abuse
• Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
• Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
• Patients treated with any non-permitted concomitant medication