Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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.
- FEV1 - Baseline and Device Comparisons [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Acapella
The Active Comparator is the Acapella, a OPEP device
8 weeks home use, twice daily
Experimental: Lung Flute
The Active Comparator is the Lung Flute, a new indication of this device
Device: Lung Flute
8 weeks home use, twice daily
No further details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560105
|United States, New York|
|VA Western NY Healthcare System|
|Buffalo, New York, United States, 14215|
|Principal Investigator:||Sanjay Sethi, MD||VA Western NY Healthcare System|