CopdNCT03534557
FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects
An observational study of Copd, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Bolivia.
Trial summary
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd
- What is being tested?
- FEV6 spirometry
- How many people
- 70 participants
- Where
- 1 siteBolivia
- Study dates
- 2 May 2018to 4 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD
Who may be able to join
- adult smoker suspected of COPD
Who cannot join
- unable to perform spirometry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population
Read the detailed description
The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.
The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC<0.70) or the lower limit of normal (FEV1/FVC<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 <0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration < LLN. Reference equations used are those of Caucasians from the NHANES III survey.
Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.
- Conditions
- Copd
- Being tested
- FEV6 spirometry
- Keywords
- spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEV6 spirometryDiagnostic test
During the same spirometry, to compare the relative value of FVC and FEV6
| Study group | Role | What they receive |
|---|---|---|
| COPD | FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients Receives: Diagnostic Test: FEV6 spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
see above
Measured: one measurement lasts 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start2 May 2018
- Primary completion18 Jun 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Liistro, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Giuseppe Liistro, MD,PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534557
- Sponsor's protocol ID
- StLucFEV6
- Status last verified
- Sep 2018
- First submitted
- 8 May 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects
- ClinicalTrials.gov ID
- NCT03534557
- Acronym / sponsor ID
- StLucFEV6
- Conditions
- Copd
- Keywords
- spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 23 May 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.
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population
Detailed description
The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.
The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC<0.70) or the lower limit of normal (FEV1/FVC<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 <0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration < LLN. Reference equations used are those of Caucasians from the NHANES III survey.
Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Diagnostic Test: FEV6 spirometryFEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD
Key inclusion criteria (1 listed)
- adult smoker suspected of COPD
Key exclusion criteria (1 listed)
- unable to perform spirometry
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 |
|---|---|---|
| FEV6 spirometryDuring the same spirometry, to compare the relative value of FVC and FEV6 | Diagnostic test | COPD |
Primary outcome
The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
Time frame: one measurement lasts 10 minutes
see above
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 5 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Giuseppe Liistro, MD,PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Copd, 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 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: finished, as of the sponsor's last update on 5 Sep 2018. 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?
The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population (time frame: one measurement lasts 10 minutes). 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 5 Sep 2018.