A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease

Inclusion criteria

• Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing.
• Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following criteria for stage ll - IV disease:

a) Subjects must have a post-bronchodilator FEV1/FEV ratio <70% and FEV1 of <80% of the predicted value for age, height, and sex using the NHANES III standards (Hankinson, 1999).

• Subjects must have a smoking history of at least 10 pack-years.
• Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period.

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Exclusion criteria

• History of an exacerbation or other significant disease instability during the month preceding enrollment.
• A primary diagnosis of asthma or bronchiectasis.
• Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.
• Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject.
• Pregnant or nursing females or females intending to become pregnant during the course of the study.
• Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit.
• Inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol.
• Patients currently using the Lung Flute. -