Pulmonary TuberculosesNCT05097638
Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.
An observational study of Pulmonary Tuberculoses and Pulmonary Function; Newborn, Abnormal, run by Assiut University at 1 site in Egypt.
Trial summary
Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Tuberculoses, Pulmonary Function; Newborn, Abnormal
- What is being tested?
- spirometry
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2018to 4 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment
Read the 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.
- Being tested
- spirometry
- Keywords
- pulmonary Tuberculosis, Spirometry, Pulmonary Function
- Medical subject headings
- Tuberculosis, Pulmonary, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
Patient do spirometry
| Study group | Role | What they receive |
|---|---|---|
| Cured pulmonary Tuberculosis patients | 6 months after a completed course of anti-tuberculosis therapy Receives: Diagnostic Test: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post tuberculosis lung functional impairment
spirometry abnormality either: restrictive, obstructive, or mixed
Measured: 6 months
post tuberculosis persistent clinical symptoms
either cough , sputum , breathlessness, hemoptysis
Measured: 6 months
Grading of obstruction function:
grading according to GOLD : mild , moderate , severe , very severe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start20 Jan 2018
- Primary completion1 Nov 2019
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Aly Mahmoud Abdel Aleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097638
- Sponsor's protocol ID
- 5884
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.
- ClinicalTrials.gov ID
- NCT05097638
- Acronym / sponsor ID
- 5884
- Keywords
- pulmonary Tuberculosis, Spirometry, Pulmonary Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cured pulmonary Tuberculosis patients | – | Diagnostic Test: spirometry6 months after a completed course of anti-tuberculosis therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patient completed an outpatient course of standard first line anti-tuberculosis therapy and declared as cured
Key exclusion criteria (10 listed)
- Smoker (to avoid spirometry biases).
- Extrapulmonary tuberculosis cases
- Multidrug resistant tuberculosis
- known contraindications to spirometry testing
- Individuals with chest wall deformities or neuromuscular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometryPatient do spirometry | Diagnostic test | Cured pulmonary Tuberculosis patients |
Primary outcome
Post tuberculosis lung functional impairment
Time frame: 6 months
spirometry abnormality either: restrictive, obstructive, or mixed
post tuberculosis persistent clinical symptoms
Time frame: 6 months
either cough , sputum , breathlessness, hemoptysis
Grading of obstruction function:
Time frame: 6 months
grading according to GOLD : mild , moderate , severe , very severe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculoses and Pulmonary Function; Newborn, Abnormal, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post tuberculosis lung functional impairment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.