Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute

NCT ID: NCT00560105

Last Updated: 2015-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.

Detailed Description

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No further details

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acapella

The Active Comparator is the Acapella, a OPEP device

Group Type ACTIVE_COMPARATOR

Acapella

Intervention Type DEVICE

8 weeks home use, twice daily

Lung Flute

The Active Comparator is the Lung Flute, a new indication of this device

Group Type EXPERIMENTAL

Lung Flute

Intervention Type DEVICE

8 weeks home use, twice daily

Interventions

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Lung Flute

8 weeks home use, twice daily

Intervention Type DEVICE

Acapella

8 weeks home use, twice daily

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age of over 40 with COPD

Exclusion Criteria

* Children,
* New mothers; and
* Women intending to become pregnant
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Acoustics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjay Sethi, MD

Role: PRINCIPAL_INVESTIGATOR

VA Western NY Healthcare System

Locations

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VA Western NY Healthcare System

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1002

Identifier Type: -

Identifier Source: org_study_id

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