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

This study has been completed.
Sponsor:
Information provided by:
Respinova LTD
ClinicalTrials.gov Identifier:
NCT00821418
First received: January 12, 2009
Last updated: May 8, 2010
Last verified: May 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821418

Locations
Israel
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yuval Avni, Respinova
ClinicalTrials.gov 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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014