SpirometrySPIROBOLIVIANCT03660111
Spirometric Predicted Values in Bolivia
A study testing spirometry in people with Spirometry and Respiratory Function Tests, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Bolivia.
Trial summary
There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spirometry, Respiratory Function Tests
- What is being tested?
- spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteBolivia
- Study dates
- 1 Jul 2018to 31 Jan 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy and non-smokers
Who cannot join
- unhealthy smokers
- subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment of Spirometric Predicted Values in Bolivia
There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.
Read the detailed description
There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.
The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.
Anthropometric variables recorded: age, sex, weight, standing and sitting height.
Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.
- Conditions
- Spirometry, Respiratory Function Tests
- Being tested
- spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
only measurement of spirometry
| Study group | Role | What they receive |
|---|---|---|
| spirometry | Other | single spirometry: only a routine diagnostic test Receives: Diagnostic Test: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume in one second (Liter)
Measured: measurements done one time at recruitment during spirometry
FVC
forced vital capacity (Liter)
Measured: measurements done one time at recruitment during spirometry
FEV1/FVC ratio
FEV1/FVC ratio , %
Measured: measurements done one time at recruitment during spirometry
Secondary outcomes (2)
Standing height
Standing height
Measured: measurements done one time at recruitment just before spirometry
seated height
seated height
Measured: measurements done one time at recruitment just before spirometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Liistro, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660111
- Sponsor's protocol ID
- SPIROBOLIVIA
- Acronym
- SPIROBOLIVIA
- Status last verified
- Mar 2019
- First submitted
- 3 Jul 2018
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the parts of the study will be available for reviewing
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Spirometric Predicted Values in Bolivia
- ClinicalTrials.gov ID
- NCT03660111
- Acronym / sponsor ID
- SPIROBOLIVIA / SPIROBOLIVIA
- Conditions
- Spirometry, Respiratory Function Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.
Detailed description
There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.
The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.
Anthropometric variables recorded: age, sex, weight, standing and sitting height.
Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spirometry | Other | Diagnostic Test: spirometrysingle spirometry: only a routine diagnostic test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy and non-smokers
Key exclusion criteria (2 listed)
- unhealthy smokers
- subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
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 |
|---|---|---|
| spirometryonly measurement of spirometry | Diagnostic test | spirometry |
Primary outcome
FEV1
Time frame: measurements done one time at recruitment during spirometry
Forced expiratory volume in one second (Liter)
FVC
Time frame: measurements done one time at recruitment during spirometry
forced vital capacity (Liter)
FEV1/FVC ratio
Time frame: measurements done one time at recruitment during spirometry
FEV1/FVC ratio , %
2 secondary outcomes
Standing height
Time frame: measurements done one time at recruitment just before spirometry
seated height
Time frame: measurements done one time at recruitment just before spirometry
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 27 Mar 2019.
- Individual participant dataSharing planned: Yes. All the parts of the study will be available for reviewing
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spirometry in people with Spirometry and Respiratory Function Tests, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Bolivia.
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 2 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 27 Mar 2019. 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 Bolivia. 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?
FEV1 (time frame: measurements done one time at recruitment during spirometry). The study lists 3 primary outcomes in all. 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 27 Mar 2019.