NCT03534557

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
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Copd

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FEV6 spirometry	During the same spirometry, to compare the relative value of FVC and FEV6

Timeline

• Start date: 2018-05-02
• Primary completion: 2018-06-18
• Completion: 2018-09-04
• First posted: 2018-05-23
• Last updated: 2018-09-05

Locations

1 site across 1 country: Bolivia