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

October 10, 2007
June 15, 2009
November 2006
Not Provided
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 ]
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. [ Time Frame: One day ]
Complete list of historical versions of study NCT00542282 on ClinicalTrials.gov Archive Site
The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ] [ Designated as safety issue: No ]
The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ]
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Not Provided
 
Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma
Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Chronic Obstructive Pulmonary Disease
  • Asthma
Not Provided
1, 2, 3
known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
August 2007
Not Provided

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00542282
DB033
No
Merav Gat/VP Clinical Affairs, Deep Breeze
Deep Breeze
Not Provided
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine
Deep Breeze
June 2009

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