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

May 8, 2010 updated by: Respinova LTD

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PulsHaler first
Device: PulseHaler treatment
treatment is for two weeks, 3 times per day
Placebo Comparator: Placebo first
Device: CPAP treatment (through a deactivated version of PulsHaler)
treatment is for two weeks, 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function tests
Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment
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
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
Within 2 hours from first treatment, and after 2 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respinova LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

May 11, 2010

Last Update Submitted That Met QC Criteria

May 8, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe