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

November 15, 2007
March 4, 2015
November 2007
December 2008   (final data collection date for primary outcome measure)
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.
Safety and efficacy of the Lung Flute versus the Acapella for the treatment of COPD in adults. Twenty-four (24) hour sputum will be collected and weighed at regular interval. Similar quantities of sputum are expected. [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00560105 on ClinicalTrials.gov Archive Site
  • 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.
  • FEV1 - Baseline and device comparisons will be performed [ Time Frame: 8 weeks ]
  • IC - Baseline and device comparisons will be performed [ Time Frame: 8 weeks ]
  • Quality of Life Questionnaire/Daily Diary [ Time Frame: 8 weeks ]
  • Use of rescue inhaler [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
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
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.
No further details
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
COPD
  • Device: Lung Flute
    8 weeks home use, twice daily
  • Device: Acapella
    8 weeks home use, twice daily
  • Active Comparator: Acapella
    The Active Comparator is the Acapella, a OPEP device
    Intervention: Device: Acapella
  • Experimental: Lung Flute
    The Active Comparator is the Lung Flute, a new indication of this device
    Intervention: Device: Lung Flute
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age of over 40 with COPD

Exclusion Criteria:

  • Children,
  • New mothers; and
  • Women intending to become pregnant
Both
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560105
1002
No
Not Provided
Not Provided
Medical Acoustics LLC
Medical Acoustics LLC
Not Provided
Principal Investigator: Sanjay Sethi, MD VA Western NY Healthcare System
Medical Acoustics LLC
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP