Spirometric Predicted Values in Bolivia | NCT03660111

Studies
Spirometric Predicted Values in Bolivia

NCT03660111

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Mar 27, 2019Actual

Enrollment

330Actual

Phase

Not Applicable

Conditions

Spirometry
Respiratory Function Tests

Interventions

spirometry

Countries

Bolivia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Jul 3, 2018

First Submission Date that Met QC Criteria

Sep 4, 2018

First Posted Date

Sep 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Liistro, Head of clinics, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
spirometry	Other	single spirometry: only a routine diagnostic test	Diagnostic Test: spirometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spirometry	Diagnostic Test	only measurement of spirometry	spirometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy and non-smokers

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica del Pulmón		Santa Cruz			Bolivia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All the parts of the study will be available for reviewing

Types

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

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013147	Spirometry

Ancestor Terms

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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