PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Inclusion Criteria:

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
• Post-bronchodilator FEV1/FVC < 0.7
• Post-bronchodilator FEV1 in the range 30% - 70% predicted
• Age: 40 years or older
• Patient signed the informed consent form

Exclusion Criteria:

• Pneumothorax in the past, per anamnesis.
• Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
• Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
• Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
• Other severe systemic disease
• Non-cooperative or non-compliant patient