SPIROBOLIVIA: Spirometric Predicted Values in Bolivia

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT03660111
• Collaborator: (none)
• Enrollment: 330
• Location: 1
• Arm: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 46.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jul 1, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. FEV1 [measurements done one time at recruitment during spirometry]

   Forced expiratory volume in one second (Liter)

2. FVC [measurements done one time at recruitment during spirometry]

   forced vital capacity (Liter)

3. FEV1/FVC ratio [measurements done one time at recruitment during spirometry]

   FEV1/FVC ratio , %

Secondary Outcome Measures

1. Standing height [measurements done one time at recruitment just before spirometry]

   Standing height

2. seated height [measurements done one time at recruitment just before spirometry]

   seated height

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Clínica del Pulmón	Santa Cruz		Bolivia

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 6, 2018
• Last Update Posted: Mar 27, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

No Results Posted as of Mar 27, 2019