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Completed

NCT Number: NCT03660111

Spirometric Predicted Values in Bolivia

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.

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Key information

Conditions

Spirometry Respiratory Function Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica del Pulmón

Santa Cruz, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy and non-smokers

Exclusion criteria

  • unhealthy smokers
  • subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements

Treatment and study plan

Spirometry

Diagnostic Test

only measurement of spirometry

Primary outcomes

  1. FEV1

    Time frame: measurements done one time at recruitment during spirometry

    Forced expiratory volume in one second (Liter)

  2. FVC

    Time frame: measurements done one time at recruitment during spirometry

    forced vital capacity (Liter)

  3. FEV1/FVC ratio

    Time frame: measurements done one time at recruitment during spirometry

    FEV1/FVC ratio , %

Secondary outcomes

  1. Standing height

    Time frame: measurements done one time at recruitment just before spirometry

    Standing height

  2. seated height

    Time frame: measurements done one time at recruitment just before spirometry

    seated height

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Establishment of Spirometric Predicted Values in Bolivia

Acronym: SPIROBOLIVIA

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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