Spirometric Predicted Values in Bolivia

NCT ID: NCT03660111

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-01-31

Brief Summary

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There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.

Detailed Description

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There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.

The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.

Anthropometric variables recorded: age, sex, weight, standing and sitting height.

Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.

Conditions

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Spirometry Respiratory Function Tests

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

subjects will be assigned to their inclusion number

Study Groups

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spirometry

single spirometry: only a routine diagnostic test

Group Type OTHER

spirometry

Intervention Type DIAGNOSTIC_TEST

only measurement of spirometry

Interventions

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spirometry

only measurement of spirometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* healthy and non-smokers

Exclusion Criteria

* unhealthy smokers
* subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Liistro

Head of clinics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clínica del Pulmón

Santa Cruz, , Bolivia

Site Status

Countries

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Bolivia

Other Identifiers

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SPIROBOLIVIA

Identifier Type: -

Identifier Source: org_study_id

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