COPDNCT01186822
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
A study testing Lung Flute in people with COPD, run by Nicolaas J Smit PhD at 1 site in United States.
Trial summary
This is a 26 week randomized controlled study. The study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be telephonic assessments at 8 weeks and 20 weeks. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Lung Flute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing.
- Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following criteria for stage ll - IV disease:
- Subjects must have a post-bronchodilator FEV1/FEV ratio <70% and FEV1 of <80% of the predicted value for age, height, and sex using the NHANES III standards (Hankinson, 1999).
- Subjects must have a smoking history of at least 10 pack-years.
- Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period.
- -
Who cannot join
- History of an exacerbation or other significant disease instability during the month preceding enrollment.
- A primary diagnosis of asthma or bronchiectasis.
- Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.
- Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject.
- Pregnant or nursing females or females intending to become pregnant during the course of the study.
- Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit.
- Inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol.
- Patients currently using the Lung Flute. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.
This is a 26 week randomized controlled study. The study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples will also be collected at these visits for microbiological and inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect information regarding compliance with the use of the Lung Flute, adverse events and exacerbation history.
- Conditions
- COPD
- Being tested
- Lung Flute
- 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
Used twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lung Flute for BHT | Experimental | The Lung Flute arm participants were instructed to blow twice in to the Lung Flute device vigorously enough to make the reed oscillate, followed by 5 normal breaths. This was repeated 10 times, followed by 3 huff coughs to complete 1 cycle. Two such cycles were recommended twice a day. One of these cycles was performed under supervision of the study personnel at the time of enrollment and at each subsequent study visit. Baseline COPD medication regimen was continued in all participants, although the primary physicians of the participants could make medically necessary changes. Chest physical therapy, additional breathing exercises and formal pulmonary rehabilitation programs were not prescribed to any of the participants during the study. Receives: Device: Lung Flute |
| No intervenstion | No intervention | No intervention. Same population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaas J Smit PhD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Nicolaas J Smit PhD, Medical Acoustics LLC
- Investigators
- Sanjay Sethi, MD, Principal investigator, VA WNY Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186822
- Sponsor's protocol ID
- LF6mo
- Status last verified
- Jan 2015
- First submitted
- 19 Aug 2010
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sethi S, Yin J, Anderson PK. Lung flute improves symptoms and health status in COPD with chronic bronchitis: A 26 week randomized controlled trial. Clin Transl Med. 2014 Sep 23;3:29. doi: 10.1186/s40169-014-0029-y. eCollection 2014.
PubMed 25625006
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01186822
- Acronym / sponsor ID
- LF6mo
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nicolaas J Smit PhDIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 26 week randomized controlled study. The study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples will also be collected at these visits for microbiological and inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect information regarding compliance with the use of the Lung Flute, adverse events and exacerbation history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Flute for BHT | Experimental | Device: Lung FluteThe Lung Flute arm participants were instructed to blow twice in to the Lung Flute device vigorously enough to make the reed oscillate, followed by 5 normal breaths. This was repeated 10 times, followed by 3 huff coughs to complete 1 cycle. Two such cycles were recommended twice a day. One of these cycles was performed under supervision of the study personnel at the time of enrollment and at each subsequent study visit. Baseline COPD medication regimen was continued in all participants, although the primary physicians of the participants could make medically necessary changes. Chest physical therapy, additional breathing exercises and formal pulmonary rehabilitation programs were not prescribed to any of the participants during the study. |
| No intervenstion | No intervention | –No intervention. Same population. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing.
- Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following criteria for stage ll - IV disease:
- Subjects must have a smoking history of at least 10 pack-years.
- Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period.
- -
Key exclusion criteria (8 listed)
- History of an exacerbation or other significant disease instability during the month preceding enrollment.
- A primary diagnosis of asthma or bronchiectasis.
- Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.
- Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject.
- Pregnant or nursing females or females intending to become pregnant during the course of the study.
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 FluteUsed twice daily | Device | Lung Flute for BHT |
Primary outcome
To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 25625006Sethi S, Yin J, Anderson PK. Lung flute improves symptoms and health status in COPD with chronic bronchitis: A 26 week randomized controlled trial. Clin Transl Med. 2014 Sep 23;3:29. doi: 10.1186/s40169-014-0029-y. eCollection 2014.
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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 WNY 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 in people with COPD, run by Nicolaas J Smit PhD 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 6 inclusion and 8 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 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186822, which also lists 1 linked publication.
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 30 Jan 2015.