NCT03660111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

July 3, 2018

Last Update Submit

March 26, 2019

Conditions

SpirometryRespiratory Function Tests

Outcome Measures

Primary Outcomes (3)

  • FEV1

    Forced expiratory volume in one second (Liter)

    measurements done one time at recruitment during spirometry

  • FVC

    forced vital capacity (Liter)

    measurements done one time at recruitment during spirometry

  • FEV1/FVC ratio

    FEV1/FVC ratio , %

    measurements done one time at recruitment during spirometry

Secondary Outcomes (2)

  • Standing height

    measurements done one time at recruitment just before spirometry

  • seated height

    measurements done one time at recruitment just before spirometry

Study Arms (1)

spirometry

OTHER

single spirometry: only a routine diagnostic test

Diagnostic Test: spirometry

Interventions

spirometryDIAGNOSTIC_TEST

only measurement of spirometry

spirometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy and non-smokers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica del Pulmón

Santa Cruz, Bolivia

Location

MeSH Terms

Interventions

Spirometry

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
subjects will be assigned to their inclusion number
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinics

Study Record Dates

First Submitted

July 3, 2018

First Posted

September 6, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

All the parts of the study will be available for reviewing

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At article submission for reviewing until final acceptation
Access Criteria
Following the reviewers' requirements

Locations

BO(1)