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

Pulmonary Tuberculoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097638
• Other study ID #: 5884
• Status: Completed
• Start date: January 20, 2018
• Est. completion date: February 4, 2020

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 4, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Function; Newborn, Abnormal
• Pulmonary Tuberculoses
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• spirometry
Patient do spirometry

Locations

Country	Name	City	State
Egypt	Chest Department-faculty of medicine-Assuit university	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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