Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)

Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation

The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.

Inclusion Criteria:

• Diagnosis of COPD
• Diagnosis established for at least 1 year;
• Post-bronchodilator FEV1/FVC < 0.7
• Post bronchodilator FEV1 <70% predicted
• Age: 40 years or older
• Smoking cigarettes, at least 10PY
• Patient signed the informed consent form

Exclusion Criteria:

• Bullous Emphysema (ruled out by recent CT)
• Hospitalization due to exacerbation of COPD within the last 3 months
• Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
• Systemic steroid treatment in the last 4 weeks
• Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
• Severe cardiac disease, e.g., CHF grade 3 or higher
• Acute MI within last 3 months
• CABG within last 3 months
• Other severe systemic disease