Clinical trial NCT04721080: Pulmonary Tuberculosis Sequelae in Patients With COPD
Official title: Effects of Pulmonary Tuberculosis Sequelae on Functional Outcomes in Patients With COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Copd
Tuberculosis
Quality of Life
Keywords: copd
tuberculosis
exercise capacity
quality of life
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with tuberculous sequelae and COPD patients without tuberculosis sequela

Brief summary: It is known that there is a complex relationship between tuberculosis and COPD. Post-tuberculosis airway disease or COPD associated with tuberculosis occurs in a significant portion of tuberculosis patients. However, it was observed that mortality rates and exacerbation rates of COPD patients with tuberculosis sequel were higher. However, the effect of tuberculosis sequela on functional outcomes in COPD patients has not been investigated in the studies.

The aim of this study is to determine whether the previous tuberculosis sequelae has a functional effect on patients with COPD.

Detailed description: This research is planned as a cross-sectional study. It will start within one week following the approval of the ethics committee and will be completed within one year. The universe of the study is S.B.Ü. Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital consists of patients who apply to Pulmonary Rehabilitation Outpatient Clinic. Participants will consist of two different groups: COPD patients with tuberculosis and COPD patients without tuberculosis. The voluntary principle will be taken into account in participating in the research.

Within the scope of the evaluation; Demographic and clinical information of the people who will participate in the study will be recorded, and Thorax CT and PFT examinations performed within the polyclinic service within the last 1 month will be evaluated. Saint George Respiratory Questionaire (SGRQ), 6-minute walk test (6MWT), Medical Research Council Dyspnea Scale (MRC), COPD assessment test (CAT) will be applied to the patients. Regarding the illness histories, the number of hospitalizations and emergency admissions in the last 1 year will be recorded. Detailed tuberculosis anamneses will also be taken from patients with tuberculosis sequelae.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being over 18 years old
* Having thorax CT in the last 1 month
* Having PFT examination performed in the last 1 month

Exclusion Criteria:

* Being in a COPD attack
* The patient has additional pulmonary comorbidity such as Lung Ca, bronchiectasis, lung fibrosis.

Primary outcomes:
measure: Exercise Capacity
timeFrame: 6 minutes- baseline
Secondary outcomes:
measure: Dyspnea Assessment
timeFrame: 5 minutes- baseline
measure: COPD Assessment
timeFrame: 5 minutes- baseline
measure: Quality of Life Assessment
timeFrame: 20 minutes- baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İlknur Naz Gürşan
Study officials:
affiliation: Izmir Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
name: Hulya Sahin
role: PRINCIPAL_INVESTIGATOR
References: