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FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534557
Enrollment
70
Registered
2018-05-23
Start date
2018-05-02
Completion date
2018-09-04
Last updated
2018-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

spirometry

Brief 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

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.

Interventions

DIAGNOSTIC_TESTFEV6 spirometry

During the same spirometry, to compare the relative value of FVC and FEV6

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult smoker suspected of COPD

Exclusion criteria

* unable to perform spirometry

Design outcomes

Primary

MeasureTime frameDescription
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 populationone measurement lasts 10 minutessee above

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026