Back to resultsA Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung Flute
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- 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:
a) 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.
-
Exclusion Criteria:
- 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. -
Sites / Locations
- VA WNY Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lung Flute for BHT
No intervenstion
Arm Description
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.
No intervention. Same population.
Outcomes
Primary Outcome Measures
To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01186822
Brief Title
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
Official Title
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicolaas J Smit PhD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Flute for BHT
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervenstion
Arm Type
No Intervention
Arm Description
No intervention. Same population.
Intervention Type
Device
Intervention Name(s)
Lung Flute
Intervention Description
Used twice daily
Primary Outcome Measure Information:
Title
To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
a) 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.
-
Exclusion Criteria:
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Sethi, MD
Organizational Affiliation
VA WNY Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA WNY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25625006
Citation
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.
Results Reference
derived
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A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease
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