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

COPD Clinical Trial

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

Clinical Trial 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 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01186822
Study type Interventional
Source Medical Acoustics LLC
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date December 2013
View Details
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