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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: CPAP treatment (through a deactivated version of PulsHaler); Device: PulseHaler treatment

• Registration Number: NCT00821418
• Lead Sponsor: Respinova LTD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Study Start: 2009-08
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-08
• Last Update Posted: 2010-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first	CPAP treatment (through a deactivated version of PulsHaler)	-
PulsHaler first	PulseHaler treatment	-

Primary Outcome Measures

Name	Time	Method
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
Health related quality of life	Within 2 hours from first treatment, and after 2 weeks of treatment

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel