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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical Acoustics LLC
ClinicalTrials.gov Identifier:
NCT00560105
First received: November 15, 2007
Last updated: March 4, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
COPD
Device: Lung Flute
Device: Acapella

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study

Further study details as provided by Medical Acoustics LLC:

Primary Outcome Measures:
  • Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • FEV1 - Baseline and Device Comparisons [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.

  • Quality of Life Questionnaire/Daily Diary [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)

  • Change in CCQ Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.


Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acapella
The Active Comparator is the Acapella, a OPEP device
Device: Acapella
8 weeks home use, twice daily
Experimental: Lung Flute
The Active Comparator is the Lung Flute, a new indication of this device
Device: Lung Flute
8 weeks home use, twice daily

Detailed Description:

No further details

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of over 40 with COPD

Exclusion Criteria:

  • Children,
  • New mothers; and
  • Women intending to become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560105

Locations
United States, New York
VA Western NY Healthcare System
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Medical Acoustics LLC
Investigators
Principal Investigator: Sanjay Sethi, MD VA Western NY Healthcare System
  More Information

No publications provided

Responsible Party: Medical Acoustics LLC
ClinicalTrials.gov Identifier: NCT00560105     History of Changes
Other Study ID Numbers: 1002
Study First Received: November 15, 2007
Results First Received: November 16, 2012
Last Updated: March 4, 2015
Health Authority: United States: Federal Government

Keywords provided by Medical Acoustics LLC:
COPD

ClinicalTrials.gov processed this record on March 26, 2015