Status:
COMPLETED
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
Lead Sponsor:
Respinova LTD
Conditions:
COPD
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01187589
Start Date
December 1 2010
End Date
September 1 2011
Last Update
September 23 2011
Active Locations (1)
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1
Assaf Harofe Medical Center Nuclear Medicine Institute
Tzrifin, Israel