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

Sponsored by:	Medical Acoustics LLC
Information provided by:	Medical Acoustics LLC
ClinicalTrials.gov Identifier:	NCT00560105

Purpose

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.

Condition	Intervention
COPD	Device: Lung Flute

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study

Further study details as provided by Medical Acoustics LLC:

Primary Outcome Measures:

Safety and efficacy of the Lung Flute versus the Acapella for the treatment of COPD in adults. Twenty-four (24) hour sputum will be collected and weighed at regular interval. Similar quantities of sputum are expected. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

FEV1 - Baseline and device comparisons will be performed [ Time Frame: 8 weeks ]
IC - Baseline and device comparisons will be performed [ Time Frame: 8 weeks ]
Quality of Life Questionnaire/Daily Diary [ Time Frame: 8 weeks ]
Use of rescue inhaler [ Time Frame: 8 weeks ]

Estimated Enrollment:	40
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2008

Arms	Assigned Interventions
Acapella: Active Comparator	Device: Lung Flute 8 weeks home use, twice daily
Lung Flute: Experimental N/A	Device: Lung Flute 8 weeks home use, twice daily

Eligibility

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

Criteria

Inclusion Criteria:

Age of over 40 with COPD

Exclusion Criteria:

Children,
New mothers; and
Women intending to become pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560105

Locations

United States, New York
VA Western NY Healthcare System
Buffalo, New York, United States, 14215

Sponsors and Collaborators

Medical Acoustics LLC

Investigators

Principal Investigator:

Sanjay Sethi, MD

VA Western NY Healthcare System

More Information

Study ID Numbers:	1002
Study First Received:	November 15, 2007
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00560105
Health Authority:	United States: Federal Government

Keywords provided by Medical Acoustics LLC:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 15, 2009