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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: August 21, 2011
Last verified: August 2011
History of Changes

November 15, 2007
August 21, 2011
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 sputum will be collected and weighed at regular interval. Similar quantities of sputum are expected. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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 will be performed [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • IC - Baseline and device comparisons will be performed [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire/Daily Diary [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Use of rescue inhaler [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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.
Not Provided
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
  • Active Comparator: Acapella
    Intervention: Device: Lung Flute
  • Experimental: Lung Flute
    N/A
    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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560105
1002
No
Medical Acoustics LLC
Medical Acoustics LLC
Not Provided
Principal Investigator: Sanjay Sethi, MD VA Western NY Healthcare System
Medical Acoustics LLC
August 2011

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