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

This study has been completed.
Information provided by:
Respinova LTD Identifier:
First received: January 12, 2009
Last updated: May 8, 2010
Last verified: May 2010

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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Device: PulseHaler treatment
Device: CPAP treatment (through a deactivated version of PulsHaler)

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

Resource links provided by NLM:

Further study details as provided by Respinova LTD:

Primary Outcome Measures:
  • Pulmonary function tests [ Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment ] [ Designated as safety issue: No ]
  • Six minute walk test [ Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: Within 2 hours from first treatment, and after 2 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00821418

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Respinova LTD
  More Information

No publications provided by Respinova LTD

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yuval Avni, Respinova Identifier: NCT00821418     History of Changes
Other Study ID Numbers: PLS-01
Study First Received: January 12, 2009
Last Updated: May 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases processed this record on April 22, 2014