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NCT03534557 Clinical Trial

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

Copd Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03534557
Other study ID # StLucFEV6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date September 4, 2018

Study information
Verified date September 2018
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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
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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 4, 2018
Est. primary completion date June 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult smoker suspected of COPD

Exclusion Criteria:

- unable to perform spirometry

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Bolivia Clínica del Pulmón Santa Cruz

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Bolivia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 one measurement lasts 10 minutes
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