Spirometric Predicted Values in Bolivia (SPIROBOLIVIA)

March 26, 2019 updated by: Giuseppe Liistro, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Establishment of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Santa Cruz, Bolivia
        • Clínica del Pulmón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy and non-smokers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: spirometry
single spirometry: only a routine diagnostic test
Diagnostic test: spirometry
only measurement of spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1
Time Frame: measurements done one time at recruitment during spirometry
Forced expiratory volume in one second (Liter)
measurements done one time at recruitment during spirometry
FVC
Time Frame: measurements done one time at recruitment during spirometry
forced vital capacity (Liter)
measurements done one time at recruitment during spirometry
FEV1/FVC ratio
Time Frame: measurements done one time at recruitment during spirometry
FEV1/FVC ratio , %
measurements done one time at recruitment during spirometry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standing height
Time Frame: measurements done one time at recruitment just before spirometry
Standing height
measurements done one time at recruitment just before spirometry
seated height
Time Frame: measurements done one time at recruitment just before spirometry
seated height
measurements done one time at recruitment just before spirometry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SPIROBOLIVIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the parts of the study will be available for reviewing

IPD Sharing Time Frame

At article submission for reviewing until final acceptation

IPD Sharing Access Criteria

Following the reviewers' requirements

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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