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

Completed · Not applicable

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT00560105

Run by

Medical Acoustics LLC

People needed

40

Starts

2007-11-01

Expected to finish

2008-12-01

Last updated by the study team

2015-03-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of over 40 with COPD

You may not qualify if…

• Children,
• New mothers; and
• Women intending to become pregnant

Where it is running

• VA Western NY Healthcare System — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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