NCT00560105

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

A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical Acoustics LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

No further details

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Lung Flute	8 weeks home use, twice daily
DEVICE	Acapella	8 weeks home use, twice daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-11-19
• Last updated: 2015-03-05
• Results posted: 2015-03-05

Locations

1 site across 1 country: United States