Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

Completed

• Conditions: Pulmonary Function; Newborn, Abnormal; Pulmonary Tuberculoses

• Registration Number: NCT05097638
• Lead Sponsor: Assiut University

Brief Summary

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment

Detailed Description

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment which may influence their quality of life. However, the pattern and nature of post-tuberculosis lung impairment is still not identified. Thus, the aim of this study was to determine the type and degree of lung physiology changes in previously treated tuberculous patients which latter may affect their quality of life; thus helping clinicians for early diagnosis of lung impairment, especially in tuberculous endemic areas.

Study Timeline

• Study Start: 2018-01-20
• Primary Completion: 2019-11-01
• Study Completion: 2020-02-04
• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-16
• Last Update Submitted: 2021-10-16
• Study First Posted: 2021-10-28
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured

Exclusion Criteria

• Smoker (to avoid spirometry biases).
• Extrapulmonary tuberculosis cases
• Multidrug resistant tuberculosis
• known contraindications to spirometry testing
• Individuals with chest wall deformities or neuromuscular diseases
• Patients who failed to achieve acceptability and reproducibility criteria of the spirometry test
• Defaulter cases or irregular treatment,
• known coexisting chronic lung disease as history of asthma or interstitial lung diseases
• A history of illicit drug use
• Patients with comorbidities: renal and hepatic insufficiency, heart diseases and metabolic disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post tuberculosis lung functional impairment	6 months	spirometry abnormality either: restrictive, obstructive, or mixed
Grading of obstruction function:	6 months	grading according to GOLD : mild , moderate , severe , very severe
post tuberculosis persistent clinical symptoms	6 months	either cough , sputum , breathlessness, hemoptysis

Trial Locations

Locations (1)

Chest Department-faculty of medicine-Assuit university; 🇪🇬 Assuit, Egypt