Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Respinova LTD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pulmonary function tests
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PulsHaler first
Intervention: PulseHaler treatment (Device)
Placebo first
Intervention: CPAP treatment (through a deactivated version of PulsHaler) (Device)
Outcomes
Primary Outcomes
Pulmonary function tests
Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Six minute walk test
Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Health related quality of life
Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Secondary Outcomes
No secondary outcomes reported