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Spirometric Predicted Values in Bolivia (SPIROBOLIVIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660111
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Giuseppe Liistro, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Spirometry Respiratory Function Tests Diagnostic Test: spirometry Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: subjects will be assigned to their inclusion number
Primary Purpose: Diagnostic
Official Title: Establishment of Spirometric Predicted Values in Bolivia
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 31, 2019
Arms and Interventions
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Arm Intervention/treatment
spirometry
single spirometry: only a routine diagnostic test
 Diagnostic Test: spirometry
only measurement of spirometry


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy and non-smokers

Exclusion Criteria:

  • unhealthy smokers
  • subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660111


Locations
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Bolivia
Clínica del Pulmón
Santa Cruz, Bolivia
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Giuseppe Liistro, Head of clinics, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03660111    
Other Study ID Numbers: SPIROBOLIVIA
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the parts of the study will be available for reviewing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At article submission for reviewing until final acceptation
Access Criteria: Following the reviewers' requirements

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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