ClinicalTrials.Veeva

Menu

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

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Conditions

Copd

Treatments

Diagnostic Test: FEV6 spirometry

Study type

Observational

Funder types

Other

Identifiers

NCT03534557
StLucFEV6

Details and patient eligibility

About

Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult smoker suspected of COPD

Exclusion criteria

  • unable to perform spirometry

Trial design

70 participants in 1 patient group

COPD
Description:
FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients
Treatment:
Diagnostic Test: FEV6 spirometry

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems