Status:
COMPLETED
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Nicolaas J Smit PhD
Conditions:
COPD
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
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 asses...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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. -
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01186822
Start Date
September 1 2010
End Date
December 1 2013
Last Update
January 30 2015
Active Locations (1)
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1
VA WNY Healthcare System
Buffalo, New York, United States, 14215