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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No intervenstion | No Intervention | No intervention. Same population. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Flute | Device | Used twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group. | 6 months |
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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.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Sethi, MD | VA WNY Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA WNY Healthcare System | Buffalo | New York | 14215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25625006 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |