Pulmonary Tuberculosis Sequelae in Patients With COPD

• Conditions: Copd; Tuberculosis; Quality of Life
• Interventions: Other: Functional Outcome Measurements

• Registration Number: NCT04721080
• Lead Sponsor: Izmir Katip Celebi University

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-27
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients with tuberculous sequelae	Functional Outcome Measurements	COPD patients with tuberculous sequelae
COPD patients without tuberculosis sequela	Functional Outcome Measurements	COPD patients with tuberculous sequelae

Primary Outcome Measures

Name	Time	Method
Exercise Capacity	6 minutes- baseline	Six minutes walk test

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment	20 minutes- baseline	St. George Respiratory Questionaire
COPD Assessment	5 minutes- baseline	COPD Assessment Test (CAT
Dyspnea Assessment	5 minutes- baseline	Medical Research Council Scale(MRC)

Trial Locations

Locations (1)

İlknur Naz Gürşan; 🇹🇷 İzmir, Turkey