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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186822
• Other study ID #: LF6mo
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: January 29, 2015
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Medical Acoustics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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:

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).

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

4. 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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Lung Flute
Used twice daily

Locations

Country	Name	City	State
United States	VA WNY Healthcare System	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaas J Smit PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group.		6 months	No