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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
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 sputum will be collected and weighed at regular interval. Similar quantities of sputum are expected. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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 Device: Lung Flute
8 weeks home use, twice daily
Experimental: Lung Flute
N/A
 Device: Lung Flute
8 weeks home use, twice daily

  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
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
Last Updated: August 21, 2011
Health Authority: United States: Federal Government

Keywords provided by Medical Acoustics LLC:
COPD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013