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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05097638
Collaborator
(none)
210
1
24.5
8.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: spirometry

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 Design

Study Type:
Observational
Actual Enrollment :
210 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.
Actual Study Start Date :
Jan 20, 2018
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Feb 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Cured pulmonary Tuberculosis patients

6 months after a completed course of anti-tuberculosis therapy

Diagnostic Test: spirometry
Patient do spirometry

Outcome Measures

Primary Outcome Measures

  1. Post tuberculosis lung functional impairment [6 months]

    spirometry abnormality either: restrictive, obstructive, or mixed

  2. post tuberculosis persistent clinical symptoms [6 months]

    either cough , sputum , breathlessness, hemoptysis

  3. Grading of obstruction function: [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chest Department-faculty of medicine-Assuit university Assuit Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nermeen Aly Mahmoud Abdel Aleem, Lecture in Chest and Tuberculosis Department, Faculty of Medicine, Assiut University
ClinicalTrials.gov Identifier:
NCT05097638
Other Study ID Numbers:
  • 5884
First Posted:
Oct 28, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nermeen Aly Mahmoud Abdel Aleem, Lecture in Chest and Tuberculosis Department, Faculty of Medicine, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2021