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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821418
• Other study ID #: PLS-01
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: May 8, 2010
• Start date: August 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: Respinova LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• PulseHaler treatment
treatment is for two weeks, 3 times per day
• CPAP treatment (through a deactivated version of PulsHaler)
treatment is for two weeks, 3 times per day

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Respinova LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function tests		Within 2 hours from first treatment, and after 2 weeks of treatment	No
Primary	Six minute walk test		Within 2 hours from first treatment, and after 2 weeks of treatment	No
Primary	Health related quality of life		Within 2 hours from first treatment, and after 2 weeks of treatment	No