COPDNCT00560105
Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
A study testing Lung Flute and Acapella in people with COPD, run by Medical Acoustics LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Lung Flute and Acapella
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of over 40 with COPD
Who cannot join
- Children,
- New mothers; and
- Women intending to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Western NY Healthcare System
Buffalo, New York, 14215
About this study
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
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.
Read the detailed description
No further details
- Conditions
- COPD
- Being tested
- Lung Flute, Acapella
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung FluteDevice
8 weeks home use, twice daily
AcapellaDevice
8 weeks home use, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Acapella | Active comparator | The Active Comparator is the Acapella, a OPEP device Receives: Device: Acapella |
| Lung Flute | Experimental | The Active Comparator is the Lung Flute, a new indication of this device Receives: Device: Lung Flute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Acoustics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjay Sethi, MD, Principal investigator, VA Western NY Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560105
- Sponsor's protocol ID
- 1002
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2007
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00560105
- Acronym / sponsor ID
- 1002
- Conditions
- COPD
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical Acoustics LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 5 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella | Active comparator | Device: AcapellaThe Active Comparator is the Acapella, a OPEP device |
| Lung Flute | Experimental | Device: Lung FluteThe Active Comparator is the Lung Flute, a new indication of this device |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age of over 40 with COPD
Key exclusion criteria (3 listed)
- Children,
- New mothers; and
- Women intending to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Flute8 weeks home use, twice daily | Device | Lung Flute |
| Acapella8 weeks home use, twice daily | Device | Acapella |
Primary outcome
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
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.
3 secondary outcomes
FEV1 - Baseline and Device Comparisons
Time frame: 8 weeks
Quality of Life Questionnaire/Daily Diary
Time frame: 8 weeks
Change in CCQ Score
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Sethi, MD principal investigator
VA Western NY Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Flute and Acapella in people with COPD, run by Medical Acoustics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.