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Clinical Trials/NCT00542282
NCT00542282
Completed
Not Applicable

Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators

Deep Breeze1 site in 1 country75 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Deep Breeze
Enrollment
75
Locations
1
Primary Endpoint
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
August 2007
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Deep Breeze

Eligibility 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.

Outcomes

Primary Outcomes

The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.

Time Frame: One day

Secondary Outcomes

  • The secondary objective is correlating the VRI evaluations with lung function test results(One day)

Study Sites (1)

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