A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease

• Sponsor: Nicolaas J Smit PhD (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01186822
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: Lung Flute	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lung Flute for BHT 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.	Device: Lung Flute; Used twice daily
No Intervention: No intervenstion No intervention. Same population.

Outcome Measures

Primary Outcome Measures

1. To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. 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:

1. 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).

1. Subjects must have a smoking history of at least 10 pack-years.

2. 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:

1. History of an exacerbation or other significant disease instability during the month preceding enrollment.

2. A primary diagnosis of asthma or bronchiectasis.

3. Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.

4. 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.

5. Pregnant or nursing females or females intending to become pregnant during the course of the study.

6. Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit.

7. 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.

8. Patients currently using the Lung Flute. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA WNY Healthcare System	Buffalo	New York	United States	14215

Sponsors and Collaborators

• Nicolaas J Smit PhD

Investigators

• Principal Investigator: Sanjay Sethi, MD, VA WNY Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicolaas J Smit PhD, Dr. S. Sethi, Medical Acoustics LLC
• ClinicalTrials.gov Identifier: NCT01186822
• Other Study ID Numbers: LF6mo
• First Posted: Aug 23, 2010
• Last Update Posted: Jan 30, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 30, 2015