Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Pulmonary Tuberculosis Clinical Trial

Official title:

Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736864
• Other study ID #: FUUMGCD
• Status: Completed
• Phase: N/A
• First received: April 2, 2016
• Last updated: February 12, 2018
• Start date: September 28, 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study assesses patients with cured pulmonary tuberculosis by compulsory notification data of Uberlândia (Minas Gerais state - Brazil) from 2012, 2013, 2014 and 2015. These patients will be invited by telephonic contact. After eligibility and exclusion criteria evaluation, those included will be assessed in order to know structural and functional repercussions of pulmonary tuberculosis sequelae.

Description:

This study evaluates structural and functional repercussions of pulmonary tuberculosis sequelae by chest imaging (computed tomography and radiograph), functional respiratory tests (spirometry and six minute walking test) in patients with cured pulmonary tuberculosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pulmonary tuberculosis with completed treatment (patients that received at least six months of treatment and with confirmed cure by negative culture and/or sputum smear, or clinical and radiological improvement after well succeed treatment);

• Treatment finalized at least one year before.

Exclusion Criteria:

• Physically impaired to perform the functional tests;

• Coexisting lung pathology (history of previous respiratory disease or clinical or radiological evidence of lung disease other than tuberculosis);

• Pregnants.

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama)	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry	High resolution computed tomography of the lungs will be evaluated by radiologists and the extent of pulmonary abnormalities will be score subjectively.; Spirometry will permit assessment of lung volumes: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).	At least one year after completion of the tuberculosis treatment