Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae

Completed

• Conditions: Pulmonary Tuberculosis

• Registration Number: NCT02736864
• Lead Sponsor: Federal University of Uberlandia

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Study Start: 2016-09-28
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between extent of pulmonary disease by computed tomography and lung volumes by spirometry	At least one year after completion of the tuberculosis treatment	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).

Trial Locations

Locations (1)

Clinical Hospital of Federal University of Uberlândia (Av. Pará, 1720 - Umuarama); 🇧🇷 Uberlândia, Minas Gerais, Brazil