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Completed

NCT Number: NCT00821418

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PulseHaler treatment

Device

treatment is for two weeks, 3 times per day

CPAP treatment (through a deactivated version of PulsHaler)

Device

treatment is for two weeks, 3 times per day

Primary outcomes

  1. Pulmonary function tests

    Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment

  2. Six minute walk test

    Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment

  3. Health related quality of life

    Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment

Sponsors and collaborators

Lead sponsor

Respinova LTD

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2009
Registry last updated
May 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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