AsbestosisNCT02280343
Oscillation Mechanics of the Respiratory System Asbestos Exposed: Early Diagnosis
An observational study of Asbestosis, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
Inhalation of dust containing asbestos results in a process of interstitial pulmonary fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory mechanics describing resistive, elastic and inertial properties. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asbestosis
- What is being tested?
- evaluated lung function
- How many people
- 2 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Mar 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: exposed to asbesto
Who may be able to join
- diagnosis of asbestosis
Who cannot join
- other diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Paula Morisco de Sá
Rio de Janeiro, Rio de Janeiro, 20550-013
Paula M de Sá, researcher, 552123340705, paulamorisco@hotmail.com
About this study
Official title: OSCILLATION MECHANICS OF THE RESPIRATORY SYSTEM ASBESTOS EXPOSED : Early Diagnosis
Inhalation of dust containing asbestos results in a process of interstitial pulmonary fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory mechanics describing resistive, elastic and inertial properties. We believe that this technique may contribute to the early diagnosis of asbestosis.
Read the detailed description
The aims of this study were (1) to use the FOT to analyze how respiratory mechanics is affected in patients with asbestos exposed, (2) to identify the best FOT parameters for the diagnosis of respiratory changes in these patients (3) Assess whether the presence of obstructive changes is associated with the smoking habit.The control group (CG) included 24 subjects with normal spirometric data and without a history of smoking or pulmonary disease formed by workers and students UERJ and FioCruz. Volunteers with asbestos exposure were from the Department of CESTEH/ FioCruz, totaling 24 exposed and 7 with diagnoses of asbestosis.
The diagnosis of asbestosis was established based on a history of substantial exposure to asbestos dusts and compatible radiological features, together with exclusion of other competing diagnoses.
The tests included a standardized questionnaire on respiratory symptoms, clinical evaluation; Plain radiography of the chest; FOT, plethysmography and spirometry, in that order.
- Conditions
- Asbestosis
- Being tested
- evaluated lung function
- Keywords
- forced oscillation tecnique, lung function, asbestosis
- Medical subject headings
- Asbestosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluated lung functionOther
lung function tests
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pulmonary mechanicals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsbestosisStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Morisco de Sá, Rio de Janeiro State University
- Investigators
- Paula Sá, research, Principal investigator, Universidade do Estado do Rio de Janeiro:Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280343
- Sponsor's protocol ID
- UERJ
- Status last verified
- Jun 2015
- First submitted
- 24 Oct 2014
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSCILLATION MECHANICS OF THE RESPIRATORY SYSTEM ASBESTOS EXPOSED : Early Diagnosis
- ClinicalTrials.gov ID
- NCT02280343
- Acronym / sponsor ID
- UERJ
- Conditions
- Asbestosis
- Keywords
- forced oscillation tecnique, lung function, asbestosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Oct 2014 (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.
Inhalation of dust containing asbestos results in a process of interstitial pulmonary fibrosis called asbestosis. The Forced Oscillation Technique (FOT) evaluates the respiratory mechanics describing resistive, elastic and inertial properties. We believe that this technique may contribute to the early diagnosis of asbestosis.
Detailed description
The aims of this study were (1) to use the FOT to analyze how respiratory mechanics is affected in patients with asbestos exposed, (2) to identify the best FOT parameters for the diagnosis of respiratory changes in these patients (3) Assess whether the presence of obstructive changes is associated with the smoking habit.The control group (CG) included 24 subjects with normal spirometric data and without a history of smoking or pulmonary disease formed by workers and students UERJ and FioCruz. Volunteers with asbestos exposure were from the Department of CESTEH/ FioCruz, totaling 24 exposed and 7 with diagnoses of asbestosis.
The diagnosis of asbestosis was established based on a history of substantial exposure to asbestos dusts and compatible radiological features, together with exclusion of other competing diagnoses.
The tests included a standardized questionnaire on respiratory symptoms, clinical evaluation; Plain radiography of the chest; FOT, plethysmography and spirometry, in that order.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- exposed to asbesto
Key inclusion criteria (1 listed)
- diagnosis of asbestosis
Key exclusion criteria (1 listed)
- other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluated lung functionlung function tests | Other | – |
Primary outcome
changes in pulmonary mechanicals
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
Related trials for Asbestosis
Enrolling by invitationObservational study
The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) Study
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
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.
Paula Sá, research principal investigator
Universidade do Estado do Rio de Janeiro:Brazil
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 Asbestosis, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2015. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Sá, research (552123340705, paulamorisco@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in pulmonary mechanicals (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2015.