Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute

NCT00560105 | Completed Results

• 1 other identifier: 1002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight

  In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.

  8 weeks

Secondary Outcomes (3)

• FEV1 - Baseline and Device Comparisons

  8 weeks

• Quality of Life Questionnaire/Daily Diary

  8 weeks

• Change in CCQ Score

  8 weeks

Study Arms (2)

Acapella

ACTIVE COMPARATOR

The Active Comparator is the Acapella, a OPEP device

Device: Acapella

Lung Flute

EXPERIMENTAL

The Active Comparator is the Lung Flute, a new indication of this device

Device: Lung Flute

Interventions

Lung Flute DEVICE

8 weeks home use, twice daily

Lung Flute

Acapella DEVICE

8 weeks home use, twice daily

Acapella

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of over 40 with COPD

You may not qualify if:

• Children,
• New mothers; and
• Women intending to become pregnant

Sponsors & Collaborators

• Medical Acoustics LLC: lead

Study Sites (1)

VA Western NY Healthcare System

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. S. Sethy
• Organization: VA WNY Health Care System

ssethi@buffalo.edu

716-862-7875

Study Officials

• Sanjay Sethi, MD

  VA Western NY Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 19, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 5, 2015
• Results First Posted: March 5, 2015

Record last verified: 2015-03

Locations

US (1)