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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 18, 2018

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

Arms, Groups and Cohorts

  • COPD
    • FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • adult smoker suspected of COPD Exclusion Criteria:
  • unable to perform spirometry
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    • Provider of Information About this Clinical Study
      • Principal Investigator: Giuseppe Liistro, Head of clinic – Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    • Overall Official(s)
      • Giuseppe Liistro, MD,PhD, Study Director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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