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

Respinova

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Device: PulseHaler treatment

Device: CPAP treatment (through a deactivated version of PulsHaler)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00821418

PLS-01

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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