Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma
| Tracking Information | |||||
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| First Received Date ICMJE | October 10, 2007 | ||||
| Last Updated Date | June 15, 2009 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. [ Time Frame: One day ] | ||||
| Change History | Complete list of historical versions of study NCT00542282 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma | ||||
| Official Title ICMJE | Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1, 2, 3
known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00542282 | ||||
| Other Study ID Numbers ICMJE | DB033 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Merav Gat/VP Clinical Affairs, Deep Breeze | ||||
| Study Sponsor ICMJE | Deep Breeze | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Deep Breeze | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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