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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PulsHaler first

Group Type EXPERIMENTAL

PulseHaler treatment

Intervention Type DEVICE

treatment is for two weeks, 3 times per day

Placebo first

Group Type PLACEBO_COMPARATOR

CPAP treatment (through a deactivated version of PulsHaler)

Intervention Type DEVICE

treatment is for two weeks, 3 times per day

Interventions

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PulseHaler treatment

treatment is for two weeks, 3 times per day

Intervention Type DEVICE

CPAP treatment (through a deactivated version of PulsHaler)

treatment is for two weeks, 3 times per day

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No