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

Study Overview
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Brief Summary
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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
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No further details

Official Title
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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

Conditions
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COPD

Intervention / Treatment
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* Device: Lung Flute
* Device: Acapella


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of over 40 with COPD Exclusion Criteria: Children, New mothers; and Women intending to become pregnant

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acapella<br>The Active Comparator is the Acapella, a OPEP device | Device: Acapella<br>* 8 weeks home use, twice daily<br>|
| Experimental: Lung Flute<br>The Active Comparator is the Lung Flute, a new indication of this device | Device: Lung Flute<br>* 8 weeks home use, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 - Baseline and Device Comparisons | 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. | 8 weeks | 
| Quality of Life Questionnaire/Daily Diary | 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) | 8 weeks | 
| Change in CCQ Score | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD