Chronic Obstructive Pulmonary DiseaseNCT00542282
Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Deep Breeze at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Keywords
- lung sounds,, airway obstruction,, asthma,, auscultation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Sounds, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1, 2, 3 | known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.
Measured: One day
Secondary outcomes (1)
The secondary objective is correlating the VRI evaluations with lung function test results
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startNov 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kalpalatha K Guntupalli, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542282
- Sponsor's protocol ID
- DB033
- Status last verified
- Jun 2009
- First submitted
- 10 Oct 2007
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
van Schayck CP, Chavannes NH. Detection of asthma and chronic obstructive pulmonary disease in primary care. Eur Respir J Suppl. 2003 Jan;39:16s-22s. doi: 10.1183/09031936.03.00040403.
PubMed 12572697Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
PubMed 17551264Dellinger RP, Jean S, Cinel I, Tay C, Rajanala S, Glickman YA, Parrillo JE. Regional distribution of acoustic-based lung vibration as a function of mechanical ventilation mode. Crit Care. 2007;11(1):R26. doi: 10.1186/cc5706.
PubMed 17316449
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators
- ClinicalTrials.gov ID
- NCT00542282
- Acronym / sponsor ID
- DB033
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma
- Keywords
- lung sounds,, airway obstruction,, asthma,, auscultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, 2, 3 | – | –known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Chest wall deformation
- Spine deformation (including severe scoliosis)
- Hirsutism
- Potentially contagious skin lesion on the back
- Skin lesion that would interfere with sensor placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.
Time frame: One day
1 secondary outcome
The secondary objective is correlating the VRI evaluations with lung function test results
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- Background: PubMed 12572697van Schayck CP, Chavannes NH. Detection of asthma and chronic obstructive pulmonary disease in primary care. Eur Respir J Suppl. 2003 Jan;39:16s-22s. doi: 10.1183/09031936.03.00040403.
- Background: PubMed 17551264Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
- Background: PubMed 17316449Dellinger RP, Jean S, Cinel I, Tay C, Rajanala S, Glickman YA, Parrillo JE. Regional distribution of acoustic-based lung vibration as a function of mechanical ventilation mode. Crit Care. 2007;11(1):R26. doi: 10.1186/cc5706.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalpalatha K Guntupalli, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by Deep Breeze at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00542282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.