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CompletedNCT03660111SPIROBOLIVIAUpdated Mar 27, 2019

Spirometric Predicted Values in Bolivia

An interventional study of spirometry in Spirometry and Respiratory Function Tests, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Bolivia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Spirometry
  • Respiratory Function Tests
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy and non-smokers

Exclusion criteria

Exclusion Criteria:

  • unhealthy smokers
  • subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
330 participants (actual)

Study arms

  • Other
    spirometry

    single spirometry: only a routine diagnostic test

    Diagnostic Test: spirometry

Interventions

  • Diagnostic testspirometry

    only measurement of spirometry

05

What researchers measure

Primary outcomes

  1. FEV1

    Forced expiratory volume in one second (Liter)

    Time frame: measurements done one time at recruitment during spirometry

  2. FVC

    forced vital capacity (Liter)

    Time frame: measurements done one time at recruitment during spirometry

  3. FEV1/FVC ratio

    FEV1/FVC ratio , %

    Time frame: measurements done one time at recruitment during spirometry

Secondary outcomes

  1. Standing height

    Standing height

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

  2. seated height

    seated height

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

06

Study locations

1 site
  • Clínica del Pulmón
    Santa Cruz, Bolivia
07

References and documents

Individual participant data

Plan to share: Yes — All the parts of the study will be available for reviewing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03660111
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Giuseppe Liistro (Head of clinics, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Sep 6, 2018
Start date
Jul 1, 2018
Primary completion
Dec 31, 2018
Completion
Jan 31, 2019
Last update
Mar 27, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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