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Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00542282
First received: October 10, 2007
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

Obstructive lung disease is usually a differential diagnostic consideration when a patient presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm airflow obstruction particularly in the primary care setting. Airflow obstruction that completely resolves after administration of a bronchodilator, by definition, excludes a diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function testing; bronchoreversibility testing is an adjunct in differentiating between asthma and COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating asthma from COPD.

Vibration response imaging (VRI) technology provides a simple, radiation-free method to image the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In this study, regional quantitative and qualitative information on vibration response is compared with spirometry in assessing lungs function of COPD and Asthma patients.


Condition
Chronic Obstructive Pulmonary Disease
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deep Breeze:

Primary Outcome Measures:
  • The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2006
Study Completion Date: August 2007
Groups/Cohorts
1, 2, 3
known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are either suspected of pulmonary obstruction or already diagnosed and are scheduled to perform a spirometry test with pre and post administration of bronchodilators will be enrolled in this study

Criteria

Inclusion Criteria:

  • Able and willing to read, understand, and provide written Informed Consent
  • Male or Female in the age range of 18-85 years
  • Patients referred for evaluation of known or suspected obstructive airways disease.
  • Subject is referred for pulmonary function testing with pre-and post- bronchodilator
  • BMI > 21
  • Patients who are treated with Bronchodilators should go through a washout period prior the VRI procedure according to the Pulmonary Function Laboratory protocol.
  • Stable clinical condition at study baseline evaluation.

Exclusion Criteria:

  • Chest wall deformation
  • Spine deformation (including severe scoliosis)
  • Hirsutism
  • Potentially contagious skin lesion on the back
  • Skin lesion that would interfere with sensor placement
  • Pregnant or lactating females.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542282

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
  More Information

Publications:

Responsible Party: Merav Gat/VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT00542282     History of Changes
Other Study ID Numbers: DB033
Study First Received: October 10, 2007
Last Updated: June 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Deep Breeze:
lung sounds,
airway obstruction,
asthma,
auscultation

Additional relevant MeSH terms:
Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013