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Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients

NCT04236076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-04-17

No results posted yet for this study

Summary

Prospective, sham controlled, interventional study to evaluate the extent to which PulseHaler improves the functional status of Chronic Obstructive Lung Disease (GOLD) II-IV Chronic obstructive pulmonary disease (COPD) patients.

Conditions

Interventions

DEVICE

PulseHaler

PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD. PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies, ranging from 3.5 Hertz (Hz) to 55Hz, and for pre-defined lengths of time.

DEVICE

Sham - control

Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.

Sponsors & Collaborators

  • Respinova LTD

    lead INDUSTRY

Principal Investigators

  • Alexander Yarmolovsky, MD · Kaplan Medical Center, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2021-05-31
Completion
2021-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236076 on ClinicalTrials.gov