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Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
NCT00560105 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Lung Flute
- DEVICE Acapella
Study Locations (1)
New York
- VA Western NY Healthcare System — Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00560105
The ClinicalTrials.gov registry entry for NCT00560105 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical Acoustics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with COPD appearing as the primary indexed condition, and to 2 interventions — of which Lung Flute is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00560105 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00560105 about?
NCT00560105 is a clinical study titled "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 de...
What is the current status of trial NCT00560105?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2007-11. Estimated completion is 2008-12.
What conditions does trial NCT00560105 study?
This clinical trial studies the following conditions: COPD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00560105?
The interventions under investigation include: Lung Flute (DEVICE), Acapella (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00560105?
This trial is sponsored by Medical Acoustics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00560105 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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