Spirometric Predicted Values in Bolivia

Respiratory Function Tests Clinical Trial

— SPIROBOLIVIA  

Official title:

Establishment of Spirometric Predicted Values in Bolivia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660111
• Other study ID #: SPIROBOLIVIA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Respiratory Function Tests
• Spirometry

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