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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03660111
Other study ID # SPIROBOLIVIA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date January 31, 2019

Study information

Verified date March 2019
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date January 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy and non-smokers

Exclusion Criteria:

- unhealthy smokers

- subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
spirometry
only measurement of spirometry

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 FEV1 Forced expiratory volume in one second (Liter) measurements done one time at recruitment during spirometry
Primary FVC forced vital capacity (Liter) measurements done one time at recruitment during spirometry
Primary FEV1/FVC ratio FEV1/FVC ratio , % measurements done one time at recruitment during spirometry
Secondary Standing height Standing height measurements done one time at recruitment just before spirometry
Secondary seated height seated height measurements done one time at recruitment just before spirometry
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