Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients

Inclusion criteria

Healthy volunteers:

• Males and females aged 18-65 years;
• Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
• Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;
• Normal blood pressure and heart rate;
• Normal electrocardiogram (ECG,12 lead);
• Normal laboratory tests;

Patients with Asthma:

• Males and females aged 21-65 years;
• BMI between 18.0 and 28.0 kg/m2;
• Non- or ex-smokers who smoked < 5 pack years and stopped smoking > 1 year;
• Normal blood pressure and heart rate;
• Normal ECG (12 lead);
• FEV1 ≥ 30% and < 80% of predicted according to European Coal and Steel Community values (ECSC)
• Reversibility of FEV1 ≥ 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol;

Patients with COPD:

• Males and females aged 40 - 70 years
• BMI between 18.0 and 30.0 kg/m2;
• Normal blood pressure and heart rate;
• Normal ECG (12 lead);
• Stable COPD within the past 4 weeks;
• Post bronchodilator FEV1 between 30% and 50% predicted values (ECSC);
• Post bronchodilator FEV1/FVC < 0.70 (absolute value);
• Minimum smoking history of 10 pack-years;

Exclusion criteria

All subjects:

• Blood donation or blood loss in the previous 8 weeks;
• Positive HIV1 or HIV2 serology;
• Positive acute or chronic Hepatitis B or Hepatitis C;
• Unsuitable veins for repeated venipuncture;
• Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception.
• History of substance abuse or positive urine drug screen;
• Abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
• Uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric clinically significant disorder;
• Participation in another clinical trial in the previous 8 weeks; participation in study using radioactive material within 1 calendar year;
• Known sensitivity to Formoterol or Beclometasone or any of the excipients;
• Concomitant severe diseases or diseases which are contra indications for the use of inhaled Beta-2-agonist or steroids;
• Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;
• Recent relevant infectious disease (less than two months);
• Flu vaccination or other vaccination within 4 weeks prior to the screening visit;

Additional exclusion criteria for healthy volunteers:

• Lung function measurements outside normal limits (normal values: FEV1/FVC > 0.70 and FEV1 and FVC > 80% for the ECSC predicted values);

Additional exclusion criteria for patients with Asthma:

• Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
• Life-threatening/unstable respiratory status within the previous 30 days;
• Requirement of supplemental oxygen therapy;
• Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit;
• Asthma exacerbation within the 4 weeks prior to inclusion.

Additional exclusion criteria for patients with COPD:

• Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
• Life-threatening/unstable respiratory status within the previous 30 days;
• Requirement of supplemental oxygen therapy;
• Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit;
• COPD exacerbation within the 4 weeks prior to inclusion;
• History of asthma or any chronic respiratory diseases other than COPD.