A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
This is a 26 week randomized controlled study. The study consists of, in order, an enrollment
 visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be
 telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive
 assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle
 walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples
 will also be collected at these visits for microbiological and inflammation analysis. Sputum
 will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be
 assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect
 information regarding compliance with the use of the Lung Flute, adverse events and
 exacerbation history.
Inclusion Criteria:

 1. 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.

 2. 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).

 3. Subjects must have a smoking history of at least 10 pack-years.

 4. 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:

 1. History of an exacerbation or other significant disease instability during the month
 preceding enrollment.

 2. A primary diagnosis of asthma or bronchiectasis.

 3. Inability to vibrate the reed of the Lung Flute® consistently because of severely
 expiratory flow rate.

 4. 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.

 5. Pregnant or nursing females or females intending to become pregnant during the course
 of the study.

 6. Use of any investigational drug within one month or 6 half-lives (which-ever is
 greater) of the enrollment visit.

 7. 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.

 8. Patients currently using the Lung Flute. -