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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Lung Flute; Device: Acapella

• Registration Number: NCT00560105
• Lead Sponsor: Medical Acoustics LLC

Brief 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

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2012-11-16
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Results First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age of over 40 with COPD

Exclusion Criteria

• Children,
• New mothers; and
• Women intending to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Flute	Lung Flute	The Active Comparator is the Lung Flute, a new indication of this device
Acapella	Acapella	The Active Comparator is the Acapella, a OPEP device

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight	8 weeks	In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.

Secondary Outcome Measures

Name	Time	Method
FEV1 - Baseline and Device Comparisons	8 weeks	Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.
Quality of Life Questionnaire/Daily Diary	8 weeks	St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)
Change in CCQ Score	8 weeks	The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.

Trial Locations

Locations (1)

VA Western NY Healthcare System; 🇺🇸 Buffalo, New York, United States