Status:
COMPLETED
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Respinova LTD
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 saturatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00821418
Start Date
August 1 2009
End Date
February 1 2010
Last Update
May 11 2010
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel