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

October 16, 2021 updated by: Nermeen Aly Mahmoud Abdel Aleem, Assiut University
Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt
        • Chest Department-faculty of medicine-Assuit university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient more than 18 years old had been newly diagnosed drug-sensitive first episode pulmonary tuberculosis, confirmed by sputum smear microscopy were included in the study. He completed an outpatient course of standard first line anti-tuberculosis therapy (6 months) and declared as cured without radiological change over the past year (in comparable with chest X-ray at the end of TB treatment).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cured pulmonary Tuberculosis patients
6 months after a completed course of anti-tuberculosis therapy
Diagnostic test: spirometry
Patient do spirometry

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2018

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

February 4, 2020

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 16, 2021

First Posted (ACTUAL)

October 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 16, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5884

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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