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OpenTrials
Completed

NCT Number: NCT05097638

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

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spirometry

Diagnostic Test

Patient do spirometry

Primary outcomes

  1. Post tuberculosis lung functional impairment

    Time frame: 6 months

    spirometry abnormality either: restrictive, obstructive, or mixed

  2. post tuberculosis persistent clinical symptoms

    Time frame: 6 months

    either cough , sputum , breathlessness, hemoptysis

  3. Grading of obstruction function:

    Time frame: 6 months

    grading according to GOLD : mild , moderate , severe , very severe

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 28, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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