PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Respinova LTD
• Treatments: Albuterol

Criteria

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