Pulmonary Disease, Chronic Obstructive
Conditions
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 saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.
Interventions
DEVICEPulseHaler treatment
treatment is for two weeks, 3 times per day
DEVICECPAP treatment (through a deactivated version of PulsHaler)
treatment is for two weeks, 3 times per day
Sponsors
Respinova LTD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health related quality of life | Within 2 hours from first treatment, and after 2 weeks of treatment |
| Pulmonary function tests | Within 2 hours from first treatment, and after 2 weeks of treatment |
| Six minute walk test | Within 2 hours from first treatment, and after 2 weeks of treatment |
Countries
Israel
Outcome results
None listed